Drug Information

The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment.

The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use.

Drug Name	Drug Reason	Date
Abecma The Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel injection) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Source: FDA website	New Drug	03-26-21
Actemra The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Source: FDA website	New Indication	03-04-21
Acyclovir Zydus Pharmaceuticals announced a voluntary recall of four lots of acyclovir sodium injection 50 mg/mL due to complaints of crystallization in vials. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/zydus-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-acyclovir-sodium-injection-50-mgml Source: FDA website	Drug Recall	03-25-21
Aduhelm The Food and Drug Administration (FDA) approved Aduhelm™ (aducanumab-avwa injection) for the treatment of Alzheimer's disease. Source: FDA website	New Drug	06-07-21
Amondys 45 The Food and Drug Administration (FDA) approved Amondys 45 (casimersen injection) for the treatment of Duchenne muscular dystrophy (DMD) in individuals who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. Source: FDA website	New Drug	02-25-21
Arcalyst The Food and Drug Administration (FDA) approved Arcalyst® (rilonacept injection) for the treatment of recurrent pericarditis and to reduce the risk of recurrence in individuals 12 years and older. Source: FDA website	New Indication	03-18-21
Azstarys The Food and Drug Administration (FDA) approved AzstarysTM (serdexmethylphenidate/dexmethylphenidate capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals age six years and older. Source: FDA website	New Drug	03-02-21
Benzedrex The Food and Drug Administration (FDA) is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/benzedrex-propylhexedrine-drug-safety-communication-fda-warns-abuse-and-misuse-nasal-decongestant Source: FDA website	Drug Warning	03-25-21
Botox The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric individuals 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. Source: FDA website	New Indication	02-09-21
Brexafemme The Food and Drug Administration (FDA) approved Brexafemme® (ibrexafungerp tablets) for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC). Source: FDA website	New Drug	06-01-21
Breyanzi The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Source: FDA website	New Drug	02-05-21
Cabenuva The Food and Drug Administration (FDA) approved Cabenuva (cabotegravir/rilpivirine extended-release injection) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Source: FDA website	New Drug	01-21-21
Camcevi The Food and Drug Administration (FDA) approved Camcevi® (leuprolide mesylate subcutaneous injection depot) for the treatment of advanced prostate cancer. Source: FDA website	New Formulation	05-25-21
Carbaglu The Food and Drug Administration (FDA) approved Carbaglu® (carglumic acid tablets for oral suspension) for adjunctive treatment of acute hyperammonemia due to propionic acidemia or methylmalonic acidemia. Source: FDA website	New Indication	01-22-21
ChloraPrep BD (Becton, Dickinson and Company) has expanded a voluntary recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible fungal contamination under certain environmental conditions. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-expands-voluntary-recall-chlorapreptm-3-ml-applicator-nationwide-include-all-us-states Source: FDA website	Drug Recall	03-22-21
Cisatracurium besylate Meitheal Pharmaceuticals announced a voluntary recall of one lot of Cisatracurium besylate injection due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meitheal-pharmaceuticals-inc-issues-voluntary-nationwide-recall-cisatracurium-besylate-injection-usp Source: FDA website	Drug Recall	01-28-21
Cosela The Food and Drug Administration (FDA) approved CoselaTM (trilaciclib injection) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Source: FDA website	New Drug	02-12-21
Cosentyx The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) to include treating moderate-to-severe plaque psoriasis in individuals as young as six years old who are candidates for systemic therapy or phototherapy. Source: FDA website	Expanded Indication	05-28-21
Curative SARS-CoV-2 Test The Food and Drug Administration (FDA) is alerting healthcare providers and consumers of the risk of false results with the Curative SARS-CoV-2 test. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication Source: FDA website	Drug Warning	01-07-21
Darzalex Faspro The Food and Drug Administration (FDA) approved Darzalex FasproTM (daratumumab/hyaluronidase-fihj injection) for the treatment of multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed individuals who are eligible for autologous stem cell transplant. Source: FDA website	New Indication	01-11-21
Darzalex Faspro The Food and Drug Administration (FDA) approved Darzalex FasproTM (daratumumab/hyaluronidase-fihj injection) for use in combination with bortezomib, cyclophosphamide and dexamethasone (VCd), to treat adults with newly diagnosed light-chain (AL) amyloidosis. Source: FDA website	New Indication	01-15-21
Diovan The Food and Drug Administration (FDA) approved Diovan® (valsartan tablets) to include individuals 1 to 5 years of age for the treatment of hypertension. Source: FDA website	New Indication	04-19-21
Edurant The Food and Drug Administration (FDA) approved Edurant® (rilpivirine tablets) in combination with cabotegravir for short-term treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as: oral lead-in to assess the tolerability of rilpivirine prior to administration of Cabenuva (cabotegravir/rilpivirine extended-release injection) or oral therapy for individuals who will miss planned injection dosing with Cabenuva. Source: FDA website	Expanded Indication	01-21-21
Empaveli The Food and Drug Administration (FDA) approved EmpaveliTM (pegcetacoplan injection) for the treatment of adults with paroxysmal nocturnal hemoglobinuria. Source: FDA website	New Drug	05-14-21
Enhertu The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Source: FDA website	New Indication	01-15-21
Enoxaparin sodium Apotex announced a voluntary recall of two lots of enoxaparin sodium injection due to mislabeling of syringe barrel measurement markings. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-enoxaparin-sodium-injection-usp-due-mislabeling Source: FDA website	Drug Recall	02-03-21
Entresto The Food and Drug Administration (FDA) approved Entresto® (sacubitril/valsartan tablets) in chronic heart failure to include individuals with heart failure with reduced ejection fraction (HFrEF), as well as many with heart failure with preserved ejection fraction (HFpEF). Source: FDA website	New Indication	02-16-21
Evekeo ODT The Food and Drug Administration (FDA) approved Evekeo ODT® (amphetamine sulfate orally disintegrating tablets) to include individuals 3 to 5 years of age for the treatment of attention deficit hyperactivity disorder (ADHD). Source: FDA website	New Indication	04-16-21
Evkeeza The Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb injection) as an add-on treatment for individuals aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Source: FDA website	New Drug	02-11-21
Exparel The Food and Drug Administration (FDA) approved Exparel® (bupivacaine liposome injection) to include use in individuals 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. Source: FDA website	Expanded Indication	03-22-21
Fabrazyme The Food and Drug Administration (FDA) approved Fabrazyme® (agalsidase beta injection) for the treatment of adult and pediatric individuals 2 years of age and older with Fabry disease. Source: FDA website	New Indication	03-11-21
Farxiga The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) to include reducing the risk of kidney function decline, kidney failure, cardiovascular (CV) death and hospitalization for heart failure (HF) in adults with chronic kidney disease (CKD) who are at risk of disease progression. Source: FDA website	New Indication	04-30-21
Ferriprox The Food and Drug Administration (FDA) approved Ferriprox® (deferiprone tablets and oral solution) for the treatment of transfusional iron overload due to sickle cell disease (SCD) or other anemias in adult and pediatric individuals 3 years of age and older. Source: FDA website	New Indication	04-30-21
Flucelvax Quadrivalent The Food and Drug Administration (FDA) approved Flucelvax® Quadrivalent (inactivated influenza vaccine injection) for active immunization in individuals 2 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website	New Indication	03-05-21
Fotivda The Food and Drug Administration (FDA) approved Fotivda® (tivozanib capsules) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Source: FDA website	New Drug	03-10-21
Gocovri The Food and Drug Administration (FDA) approved Gocovri® (amantadine extended-release capsules) as an adjunctive treatment to levodopa/carbidopa in individuals with Parkinson’s disease experiencing OFF episodes. Source: FDA website	New Indication	02-01-21
Guanfacine Apotex announced a voluntary recall of three lots of guanfacine extended-release tablets 2 mg due to trace amounts of quetiapine fumarate in one lot. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-guanfacine-extended-release-tablets-2mg-due-trace Source: FDA website	Drug Recall	03-31-21
Humira The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of moderately to severely active ulcerative colitis in pediatric individuals 5 years of age and older. Source: FDA website	New Indication	02-24-21
Jemperli The Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly injection) for the treatment of adults with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen. Source: FDA website	New Drug	04-22-21
Ketorolac tromethamine Fresenius Kabi announced a voluntary recall of a single lot of ketorolac tromethamine injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp-due-presence Source: FDA website	Drug Recall	01-10-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with platinum and fluoropyrimidine-based chemotherapy for individuals with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. Source: FDA website	New Indication	03-22-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of individuals with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Source: FDA website	New Indication	05-05-21
Kimyrsa The Food and Drug Administration (FDA) approved Kimyrsa™ (oritavancin injection) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). Source: FDA website	New Drug	03-15-21
Kloxxado The Food and Drug Administration (FDA) approved Kloxxado™ (naloxone hydrochloride nasal spray) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Source: FDA website	New Formulation	04-29-21
Lamictal A Food and Drug Administration (FDA) review of a study showed a potential increased risk of heart rhythm problems in individuals with heart diease who are taking Lamictal (lamotrigine). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/lamictal-lamotrigine-drug-safety-communication-studies-show-increased-risk-heart-rhythm-problems Source: FDA website	Drug Warning	03-21-21
Levothyroxine sodium The Food and Drug Administration (FDA) approved Levothyroxine sodium 100 mcg/mL intravenous solution for the treatment of myxedema coma. Source: FDA website	New Formulation	05-17-21
Libtayo The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab-rwlc injection) for individuals with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Source: FDA website	New Indication	02-09-21
Libtayo The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab-rwlc injection) for individuals with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Source: FDA website	New Indication	02-22-21
Lorbrena The Food and Drug Administration (FDA) approved Lorbrena® (lorlatinib tablets) for first-line treatment of individuals with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Source: FDA website	New Indication	03-03-21
Lumakras The Food and Drug Administration (FDA) approved LumakrasTM (sotorasib tablets) for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Source: FDA website	New Drug	05-28-21
Lupkynis The Food and Drug Administration (FDA) approved LupkynisTM (voclosporin capsules) in combination with a background immunosuppressive therapy regimen for the treatment of adults with active lupus nephritis. Source: FDA website	New Drug	01-22-21
Lybalvi The Food and Drug Administration (FDA) approved Lybalvi™ (olanzapine/samidorphan tablets) for the treatment of schizophrenia and bipolar 1 disorder in adults. Source: FDA website	New Drug	05-28-21
Medical Action Industries Medical Action Industries announced a voluntary recall of Medical Convenience Kits that include the BD/Carefusion Chloraprep 3 mL applicator due to risk of fungal contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/medical-action-industries-inc-306-recalls-medical-convenience-kits-risk-fungal-aspergillus Source: FDA website	Drug Recall	05-24-21
Myfembree The Food and Drug Administration (FDA) approved Myfembree® (relugolix/estradiol/norethindrone acetate tablets) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Source: FDA website	New Drug	05-26-21
Myrbetriq The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release oral suspension) for neurogenic detrusor overactivity (NDO) in pediatric individuals aged 3 years and older and weighing 35 kg or more. Source: FDA website	New Formulation	03-25-21
Myrbetriq The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for neurogenic detrusor overactivity (NDO) in pediatric individuals aged 3 years and older and weighing 35 kg or more. Source: FDA website	Expanded Indication	03-25-21
Natroba The Food and Drug Administration (FDA) approved Natroba™ (spinosad topical suspension) for the treatment of scabies infestations in individuals 4 years of age and older. Source: FDA website	New Indication	04-28-21
Nextstellis The Food and Drug Administration (FDA) approved Nextstellis® (drospirenone/estetrol tablets) for use by females of reproductive potential to prevent pregnancy. Source: FDA website	New Drug	04-15-21
Nostrum Laboratories Nostrum Laboratories announced a voluntary recall of one additional lot of extended release metformin due to N-nitrosodimethylamine (NDMA) content above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website	Drug Recall	01-26-21
Nostrum Laboratories Nostrum Laboratories announced a voluntary recall of one additional lot of extended release metformin due to NDMA content above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_medium=email&utm_source=govdelivery Source: FDA website	Drug Recall	01-06-21
Nostrum Laboratories Nostrum Laboratories announced a voluntary recall of one lot of metformin extended release 750 mg tablets due to N-nitrosodimethylamine (NDMA) content above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets Source: FDA website	Drug Recall	01-05-21
Novo Nordisk Insulins Novo Nordisk announced a voluntary recall of 1,468 product samples of Levemir® (insulin detemir injection), Tresiba® (insulin degludec injection), Fiasp® (insulin aspart injection), Novolog® (insulin aspart injection), and Xultophy® (insulin degludec/liraglutide injection) because they were stored at temperatures below storage requirements. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novo-nordisk-issues-voluntary-nationwide-recall-levemirr-tresibar-fiaspr-novologr-and-xultophyr Source: FDA website	Drug Recall	05-10-21
NP Thyroid Acella Pharmaceuticals announced a voluntary recall of certain lots of NP Thyroid® (15 mg, 30 mg, 60 mg, 90 mg, and 120 mg levothyroxine/liothyronine tablets) due to sub potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid-0 Source: FDA website	Drug Recall	05-01-21
Nplate The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) to increase survival in adults and in pediatric individuals (including term neonates) acutely exposed to myelosuppressive doses of radiation. Source: FDA website	New Indication	01-28-21
Nulibry The Food and Drug Administration (FDA) approved NulibryTM (fosdenopterin injection) to reduce the risk of mortality in individuals with molybdenum cofactor deficiency (MoCD) Type A. Source: FDA website	New Drug	02-26-21
Nurtec ODT The Food and Drug Administration (FDA) approved Nurtec® ODT (rimegepant orally disintegrating tablets) for the preventive treatment of episodic migraine in adults. Source: FDA website	New Indication	05-27-21
Ocaliva The Food and Drug Administration (FDA) is restricting the use of Ocaliva® (obeticholic acid tablets) in individuals with primary biliary cholangitis with advanced liver cirrhosis due to the potential for serious harm. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-due-risk-serious-liver Source: FDA website	Drug Warning	05-26-21
Opdivo The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with Cabometyx (cabozantinib tablets) as first-line treatment for individuals with advanced renal cell carcinoma. Source: FDA website	Expanded Indication	01-22-21
Opdivo The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for individuals with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Source: FDA website	New Indication	05-20-21
Opdivo The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with certain types of chemotherapy, for the initial treatment of individuals with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. Source: FDA website	New Indication	04-16-21
Panzyga The Food and Drug Administration (FDA) approved Panzyga® (immune globulin injection) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Source: FDA	New Indication	02-11-21
Paroex Precision Dose announced a voluntary recall of all lots of Paroex® (chlorhexidine gluconate oral rinse) due to potential for microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-paroex-chlorhexidine-gluconate-oral-rinse-usp Source: FDA website	Drug Recall	01-05-21
Pepaxto The Food and Drug Administration (FDA) approved Pepaxto® (melphalan flufenamide injection) in combination with dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. Source: FDA website	New Drug	02-26-21
Phenylephrine Sagent Pharmaceuticals announced a voluntary recall of three lots of phenylephrine hydrochloride injection due to potentially loose crimped vial overseals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-phenylephrine-hydrochloride-injection Source: FDA website	Drug Recall	03-12-21
Ponvory The Food and Drug Administration (FDA) approved Ponvory™ (ponesimod tablets) for the treatment of adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Source: FDA website	New Drug	03-18-21
Posimir The Food and Drug Administration (FDA) approved Posimir® (bupivacaine solution for infiltration use) in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Source: FDA website	New Formulation	02-01-21
Praluent The Food and Drug Administration (FDA) approved Praluent™ (alirocumab injection) for adults with homozygous familial hypercholesterolemia (HoFH). Praluent is not intended to be used alone but instead added to other treatments for HoFH. Source: FDA website	New Indication	04-01-21
Qelbree The Food and Drug Administration (FDA) approved Qelbree™ (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric individuals 6 to 17 years of age. Source: FDA website	New Drug	04-02-21
Ragwitek The Food and Drug Administration (FDA) approved Ragwitek® (short ragweed pollen allergen extract tablet for sublingual use) to include individuals 5 to 17 years of age for the treatment of short ragweed pollen-induced allergic rhinitis. Source: FDA website	New Indication	04-19-21
Rapivab The Food and Drug Administration (FDA) approved Rapivab® (peramivir injection) for the treatment of acute uncomplicated influenza in individuals 6 months and older who have been symptomatic for no more than two days. Source: FDA website	Expanded Indication	01-28-21
Roszet The Food and Drug Administration (FDA) approved Roszet® (rosuvastatin calcium/ezetimibe tablets) as an adjunct to diet in individuals with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C) and alone or as an adjunct to other LDL-C lowering therapies in individuals with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. Source: FDA website	New Formulation	03-23-21
Rybrevant The Food and Drug Administration (FDA) approved RybrevantTM (amivantamab-vmjw injection) for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Source: FDA website	New Drug	05-21-21
Ryplazim The Food and Drug Administration (FDA) approved Ryplazim® (plasminogen injection) for the treatment of individuals with plasminogen deficiency type 1. Source: FDA website	New Drug	06-04-21
Sarclisa The Food and Drug Administration (FDA) approved Sarclisa® (isatuximab injection) in combination with carfilzomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. Source: FDA website	New Indication	03-31-21
Spironolactone Bryant Ranch Prepack announced a voluntary recall of 4 lots of spironolactone tablets due to mislabeling with the incorrect strength. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-spironolactone-25-mg-and-50-mg-tablets-due Source: FDA website	Drug Recall	03-10-21
Spritam The Food and Drug Administration (FDA) approved Spritam® (levetiracetam tablets) for the treatment of partial-onset seizures in individuals 4 years of age and older weighing more than 20 kg. Source: FDA website	Expanded Indication	01-19-21
Telmisartan Alembic Pharmaceuticals announced a voluntary recall of one lot of telmisartan tablets 20 mg due to a label mix-up. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alembic-pharmaceuticals-limited-issues-voluntary-nationwide-recall-telmisartan-tablets-usp-20-mg-due Source: FDA website	Drug Recall	03-25-21
Tembexa The Food and Drug Administration (FDA) approved Tembexa® (brincidofovir tablets and oral suspension) for the treatment of human smallpox disease in adult and pediatric individuals, including neonates. Source: FDA website	New Drug	06-04-21
Tepmetko The Food and Drug Administration (FDA) approved Tepmetko® (tepotinib tablets) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Source: FDA website	New Drug	02-03-21
Trodelvy The Food and Drug Administration (FDA) approved Trodelvy® (sacituzumab govitecan-hziy injection) for use in adults with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Source: FDA website	New Indication	04-13-21
Truseltiq The Food and Drug Administration (FDA) approved Truseltiq™ (infilgratinib capsules) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Source: FDA website	New Drug	05-28-21
Tyvaso The Food and Drug Administration (FDA) approved Tyvaso® (treprostinil oral inhalation solution) for the treatment of individuals with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Source: FDA website	New Indication	03-31-21
Ukoniq The Food and Drug Administration (FDA) approved Ukoniq® (umbralisib tablets) for the treatment of adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Source: FDA website	New Drug	02-05-21
Ultomiris The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab injection) to treat individuals aged one month and older with paroxysmal nocturnal hemoglobinuria (PNH). Source: FDA website	Expanded Indication	06-07-21
Verquvo The Food and Drug Administration (FDA) approved Verquvo® (vericiguat tablets) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%. Source: FDA website	New Drug	01-20-21
Vocabria The Food and Drug Administration (FDA) approved Vocabria (cabotegravir tablets) in combination with rilpivirine for short-term treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as: oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir/rilpivirine extended-release injection) or oral therapy for individuals who will miss planned injection dosing with Cabenuva. Source: FDA website	New Drug	01-21-21
Vyxeos The Food and Drug Administration (FDA) approved Vyxeos® (daunorubicin/cytarabine injection) to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric individuals aged one year and older. Source: FDA website	Expanded Indication	03-30-21
Wegovy The Food and Drug Administration (FDA) approved Wegovy™ (semaglutide injection) as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults. Source: FDA website	New Drug	06-04-21
Xalkori The Food and Drug Administration (FDA) approved Xalkori® (crizotinib capsules) for pediatric individuals 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Source: FDA website	Expanded Indication	01-14-21
Xeljanz and Xeljanz XR The Food and Drug Administration (FDA) is alerting consumers that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz® (tofacitinib tablets) and Xeljanz® XR (tofacitinib extended-release tablets) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. The FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-initial-safety-trial-results-find-increased Source: FDA website	Drug Warning	02-04-21
Yervoy The Food and Drug Administration (FDA) approved Yervoy® (ipilimumab injection) in combination with nivolumab for the treatment of adults with unresectable or metastatic melanoma. Source: FDA website	Expanded Indication	05-25-21
Yescarta The Food and Drug Administration (FDA) approved Yescarta® (axicabtagene ciloleucel injection) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website	New Indication	03-05-21
Zegalogue The Food and Drug Administration (FDA) approved Zegalogue® (dasiglucagon injection) for the treatment of severe hypoglycemia in pediatric and adult individuals with diabetes aged 6 years and above. Source: FDA website	New Drug	03-22-21
Zeposia The Food and Drug Administration (FDA) approved Zeposia® (ozanimod capsules) for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Source: FDA website	New Indication	05-27-21
Zipsor The Food and Drug Administration (FDA) approved Zipsor® (diclofenac potassium capsules) for relief of mild to moderate acute pain in pediatric individuals 12 years of age and older. Source: FDA website	Expanded Indication	05-25-21
Zynlonta The Food and Drug Administration (FDA) approved Zynlonta™ (loncastuximab tesirine-lpyl injection) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. Source: FDA website	New Drug	04-23-21
Zynrelef The Food and Drug Administration (FDA) approved ZynrelefTM (bupivacaine/meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. Source: FDA website	New Drug	05-12-21
Trikafta The Food and Drug Administration (FDA) approved Trikafta® (elexacaftor/tezacaftor/ivacaftor tablets) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data. Source: FDA website	Expanded Indication	06-08-21
Epclusa The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets and oral pellets) for the treatment of chronic hepatitis C virus (HCV) in children as young as 3 years of age, regardless of HCV genotype or liver disease severity. Source: FDA website	Expanded Indication	06-10-21
Mavyret The Food and Drug Administration (FDA) approved Mavyret® (glecaprevir/pibrentasvir tablet and oral pellets) for the treatment of chronic hepatitis C virus (HCV) in children as young as 3 years of age, regardless of HCV genotype or liver disease severity. Source: FDA website	Expanded Indication	06-10-21
Ayvakit The Food and Drug Administration (FDA) approved Ayvakit® (avapritinib) for adults with advanced systemic mastocytosis (AdvSM), including those with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Source: FDA website	New Indication	06-16-21
Soaanz The Food and Drug Administration (FDA) approved Soaanz® (torsemide tablets) in adults for the treatment of edema associated with heart failure or renal disease. Source: FDA website	New Formulation	06-14-21
Prevnar 20 The Food and Drug Administration (FDA) approved Prevnar 20™ (pneumococcal 20-valent conjugate vaccine) for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older. Source: FDA website	New Formulation	06-08-21
Metformin Viona Pharmaceuticals announced a voluntary recall of two lots of metformin hydrochloride extended-release 750 mg tablets due to the detection of nitrosodimethylamine (NDMA) impurities above acceptable daily limits. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets Source: FDA website	Drug Recall	06-13-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with locally advanced cutaneous squamous cell carcinoma (cSCC) that cannot be cured by surgery or radiation. Source: FDA website	New Indication	07-01-21
Padcev The Food and Drug Administration (FDA) approved Padcev® (enfortumab vedotin-ejfv injection) for adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Source: FDA website	New Indication	07-09-21
Solosec The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules) for the treatment of trichomoniasis in adults. Source: FDA website	New Indication	06-30-21
Toviaz The Food and Drug Administration (FDA) approved Toviaz® (fesoterodine fumarate extended-release tablets) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric individuals 6 years of age and older and weighing greater than 25 kg. Source: FDA website	New Indication	06-17-21
Pradaxa The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate oral pellets and capsules) to treat children 3 months to less than 12 years old with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa to prevent recurrent clots among individuals 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. Source: FDA website	New Formulation/Expanded Indication	06-21-21
Verkazia The Food and Drug Administration (FDA) approved Verkazia™ (cyclosporine ophthalmic emulsion) for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Source: FDA website	New Drug	06-23-21
Rylaze The Food and Drug Administration (FDA) approved Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult individuals one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Source: FDA website	New Drug	06-30-21
Kerendia The Food and Drug Administration (FDA) approved Kerendia® (finerenone tablets) to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. Source: FDA website	New Drug	07-09-21
DeRoyal Industries DeRoyal Industries announced a voluntary recall of surgical procedure packs due to the packs containing 1% lidocaine that has been mislabeled as 0.5% bupivacaine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/deroyal-industries-recalls-surgical-procedure-packs-mislabeled-lidocaine Source: FDA website	Drug Recall	06-25-21
Topotecan Teva Pharmaceuticals announced a voluntary recall of one lot of topotecan 4 mg/1 mL injection due to reports of particulates. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-one-lot-topotecan-injection-4-mg4-ml-1-mgml-due-presence Source: FDA website	Drug Recall	07-01-21
Avid Medical Avid Medical announced a voluntary recall of medical convenience kits that include the BD/Carefusion Chloraprep™ 3 mL applicator due to risk of fungal contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/avid-medical-recalls-medical-convenience-kits-risk-fungal-contamination Source: FDA website	Drug Recall	06-25-21
Chantix Pfizer announced a voluntary recall of nine lots of the smoking cessation drug Chantix® (varenicline tablets) due to potential levels of a nitrosamine impurity, called N-nitroso-varenicline, above the Food and Drug Administration (FDA) acceptable intake limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse Source: FDA website	Drug Recall	07-02-21
Darzalex Faspro The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab/hyaluronidase-fihj injection) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Source: FDA website	Expanded Indication	07-09-21
ArmonAir Digihaler The Food and Drug Administration (FDA) approved ArmonAir® Digihaler® (fluticasone propionate oral inhaler) for the maintenance treatment of asthma as prophylactic therapy in pediatric individuals aged 4 to 11 years. Source: FDA website	Expanded Indication	07-09-21
Prograf The Food and Drug Administration (FDA) approved Prograf® (tacrolimus injection, capsule, and oral suspension) for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric individuals receiving lung transplantation. Source: FDA website	Expanded Indication	07-16-21
Vaxneuvance The Food and Drug Administration (FDA) approved Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. Source: FDA website	New Formulation	07-16-21
Rezurock The Food and Drug Administration (FDA) approved Rezurock™ (belumodsudil tablets) for the treatment of adult and pediatric individuals 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. Source: FDA website	New Drug	07-16-21
Fexinidazole The Food and Drug Administration (FDA) approved Fexinidazole tablets for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in individuals 6 years of age and older and weighing at least 20 kg. Source: FDA website	New Drug	07-16-21
Innoveix Pharmaceuticals Innoveix Pharmaceuticals announced a voluntary recall of all lots of sterile compounded drug products within expiry due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack-0 Source: FDA website	Drug Recall	07-14-21
Bydureon; Bydureon Bcise The Food and Drug Administration (FDA) approved Bydureon™ (exenatide extended-release for injectable suspension) and Bydureon® BCise™ (exenatide extended-release injectable suspension) to be used in addition to diet and exercise to improve glycemic control in pediatric individuals 10 years or older with type 2 diabetes. Source: FDA website	Expanded Indication	07-22-21
Octagam 10% The Food and Drug Administration (FDA) approved Octagam® 10% (immune globulin, human, injection) for the treatment of adult dermatomyositis. Source: FDA website	New Indication	07-20-21
Bylvay The Food and Drug Administration (FDA) approved Bylvay™ (odevixibat oral capsules and pellets) for the treatment of pruritus (moderate to severe itching) in individuals with progressive familial intrahepatic cholestasis (PFIC) 3 months of age or older. Source: FDA website	New Drug	07-20-21
Chantix Pfizer announced an expansion of a previous voluntary recall of Chantix™ (varenicline tablets) to 12 lots due to the presence of N-nitroso-varenicline above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso Source: FDA website	Drug Recall	07-19-21
Dalvance The Food and Drug Administration (FDA) approved Dalvance® (dalbavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals from birth. Source: FDA website	Expanded Indication	07-22-21
Shingrix The Food and Drug Administration (FDA) approved Shingrix (zoster vaccine recombinant adjuvanted suspension for intramuscular injection) in adults aged 18 years and older who are or will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy. Source: FDA website	Expanded Indication	07-23-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. Source: FDA website	Expanded Indication	07-26-21
Botox The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) to include 8 new muscles for the treatment of upper limb spasticity in adults, along with the use of ultrasound as a muscle localization technique in adult spasticity. Source: FDA website	Expanded Indication	07-28-21
Drizalma Sprinkle The Food and Drug Administration (FDA) approved Drizalma SprinkleTM (duloxetine hydrochloride delayed release capsules) for the treatment of fibromyalgia in adults. Source: FDA website	New Indication	07-23-21
Nucala The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years of age and older with inadequate response to nasal corticosteroids. Source: FDA website	New Indication	07-29-21
Twyneo The Food and Drug Administration (FDA) approved Twyneo® (tretinoin/benzoyl peroxide topical cream) for the treatment of acne vulgaris in adults and pediatric individuals nine years of age and older. Source: FDA website	New Formulation	07-26-21
Pepaxto The Food and Drug Administration (FDA) is alerting consumers and health care providers that a clinical trial evaluating Pepaxto® (melphalan flufenamide injection) with dexamethasone to treat individuals with multiple myeloma showed an increased risk of death. The FDA continues to evaluate this issue and will provide an update when new information is available. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased	Drug Warning	07-28-21
Xywav The Food and Drug Administration (FDA) approved Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) for idiopathic hypersomnia (IH) in adults. Source: FDA website	New Indication	08-12-21
Opdivo The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the adjuvant treatment of individuals with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. Source; FDA website	New Indication	08-19-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with lenvatinib for the first-line treatment of adults with advanced renal cell carcinoma (RCC). Source: FDA website	Expanded Indication	08-10-21
Mirena The Food and Drug Administration (FDA) approved Mirena® (levonorgestrel intrauterine device) for duration of use up to 8 years for the prevention of pregnancy. Source: FDA website	Expanded Indication	08-12-22
Auvelity The Food and Drug Administration (FDA) approved Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults. Source: FDA website	New Formulation	08-18-22
Zynteglo The Food and Drug Administration (FDA) approved Zynteglo® (betibeglogene autotemcel injection) for the treatment of adult and pediatric individuals with beta-thalassemia who require regular red blood cell (RBC) transfusions. Source: FDA website	New Drug	08-17-22
Glatiramer acetate autoinjector devices The Food and Drug Administration (FDA) is alerting consumers and healthcare providers that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector Source: FDA website	Drug Warning	08-18-22
Uptravi The Food and Drug Administration (FDA) approved Uptravi® (selexipag injection for intravenous use) for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. Source: FDA website	New Formulation	07-30-21
Ticovac The Food and Drug Administration (FDA) approved Ticovac™ (tick-borne encephalitis vaccine injection) for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older. Source: FDA website	New Vaccine	08-13-21
Saphnelo The Food and Drug Administration (FDA) approved Saphnelo™ (anifrolumab-fnia injection) for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Source: FDA website	New Drug	07-30-21
Nexviazyme The Food and Drug Administration (FDA) approved Nexviazyme® (avalglucosidase alfa-ngpt injection) for the treatment of individuals 1 year of age and older with late-onset Pompe disease. Source: FDA website	New Drug	08-06-21
Welireg The Food and Drug Administration (FDA) approved Welireg™ (belzutifan tablets) for treatment of adults with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Source: FDA website	New Drug	08-13-21
Atovaquone KVK Tech announced a voluntary recall of two lots of atovaquone oral suspension 750 mg/5 mL due to complaints of unusual grittiness. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5ml-due Source: FDA website	Drug Recall	08-10-21
Sodium bicarbonate SterRx announced a voluntary recall of three lots of sodium bicarbonate 5% dextrose injection 150 mEq per 1,000 mL due to waterborne microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-5-dextrose-injection-150meq-1000-ml Source: FDA website	Drug Recall	08-11-21
Chantix Pfizer announced a voluntary recall of an additional four lots of the smoking cessation agent Chantix® (varenicline tablets) due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-four-additional-lots-chantixr-varenicline-tablets Source: FDA website	Drug Recall	08-17-21
Xarelto The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) in combination with aspirin to reduce the risk of major thrombotic vascular events in individuals with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Source: FDA website	New Indication	08-23-21
Tibsovo The Food and Drug Administration (FDA) approved TIbsovo® (ivosidenib tablets) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by a Food and Drug Administered (FDA)-approved test. Source: FDA website	New Indication	08-25-21
Skytrofa The Food and Drug Administration (FDA) approved Skytrofa® (lonapegsomatropin-tcgd injection) to treat pediatric individuals age one year and older who weigh at least 11.5 kg (25.4 pounds) and have short stature due to inadequate secretion of endogenous growth hormone. Source: FDA website	New Formulation	08-25-21
Korsuva The Food and Drug Administration (FDA) approved Korsuva™ (difelikefalin injection) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). Source: FDA website	New Drug	08-23-21
Briviact The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets, oral solution, and injection) to include treatment of partial-onset seizures in individuals 1 month of age and older. Source: FDA website	Expanded Indication	08-27-21
Brukinsa The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules) for adults with Waldenström's macroglobulinemia (WM). Source: FDA website	New Indication	08-31-21
Invega Hafyera The Food and Drug Administration (FDA) approved Invega Hafyera™ (paliperidone palmitate injection) twice-yearly injectable for the treatment of schizophrenia in adults. Source: FDA website	New Formulation	08-30-21
Trudhesa The Food and Drug Administration (FDA) approved Trudhesa™ (dihydroergotamine mesylate nasal inhalation) for the acute treatment of migraine with or without aura in adults. Source: FDA website	New Formulation	09-03-21
Lidocaine Teligent announced a voluntary recall of one lot of lidocaine HCL topical solution 4% due to super potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-voluntary-recall-lidocaine-hcl-topical-solution-4-lot-14218-exp-092022 Source: FDA website	Drug Recall	09-03-21
Janus kinase (JAK) inhibitors The Food and Drug Administration (FDA) is requiring revisions to the Boxed Warning for Xeljanz®/Xeljanz XR® (tofacitinib tablets), Olumiant® (baricitinib tablets) and Rinvoq™ (upadacitinib tablets) to include information about the risks of serious heart-related events, cancer, blood clots, and death. Contact your healthcare provider with questions. More details may be viewed at :https://www.fda.gov/safety/medical-product-safety-information/janus-kinase-jak-inhibitors-drug-safety-communication-fda-requires-warnings-about-increased-risk?utm_medium=email&utm_source=govdelivery Source: FDA website	Drug Recall	09-03-21
Brukinsa The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules) for the treatment of adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Source: FDA website	New Indication	09-14-21
Exkivity The Food and Drug Administration (FDA) approved Exkivity™ (mobocertinib capsules) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by a FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Source: FDA website	New Drug	09-15-21
Aminosyn II 15% ICU Medical announced a voluntary recall of one lot of Aminosyn® (amino acids injection) II 15% due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-voluntary-nationwide-recall-aminosyn-ii-15-amino-acid-injection-sulfite-free-iv Source: FDA website	Drug Recall	09-09-21
Chantix The Food and Drug Administration (FDA) announced a voluntary recall to include all lots of Chantix® (varenicline tablets) due to the presence of unacceptable N-nitroso-varenicline levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n Source: FDA website	Drug Recall	09-17-21
Firvanq Azurity Pharmaceuticals announced a voluntary recall of one lot of Firvanq® (vancomycin hydrochloride for oral solution) due to a mix-up of the diluent included in the kit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-one-lot-firvanqr-vancomycin	Drug Recall	09-09-21
Ruzurgi Jacobus Pharmaceutical Company announced a voluntary recall of 3 lots of Ruzurgi® (amifampridine10 mg tablets) due to yeast, mold, and bacterial contamination based on laboratory test results. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-inc-issues-voluntary-worldwide-recall-ruzurgir-amifampridine-10-mg Source: FDA website	Drug Recall	09-15-21
Greenpark Compounding Pharmacy The Food and Drug Administration (FDA) alerted consumers and healthcare providers not to use compounded products intended to be sterile that were produced and distributed in the United States by Prescription Labs doing business as Greenpark Compounding Pharmacy due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-not-use-compounded-products-intended-be-sterile?utm_medium=email&utm_source=govdelivery Source: FDA website	Drug Warning	09-17-21
Cabometyx The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for the treatment of adult and pediatric individuals 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. Source: FDA website	New Indication	09-17-21
Jakafi The Food and Drug Administration (FDA) approved Jakafi® (ruxolitinib tablets) for the treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric individuals 12 years and older. Source: FDA website	New Indication	09-22-21
Lexette The Food and Drug Administration (FDA) approved Lexette™ (halobetasol propionate topical foam) to include individuals 12 years of age and older with plaque psoriasis. Source: FDA website	Expanded Indication	08-18-21
Opzelura The Food and Drug Administration (FDA) approved Opzelura™ (ruxolitinib cream) for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised individuals 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website	New Formulation	09-21-21
Tivdak The Food and Drug Administration (FDA) approved Tivdak™ (tisotumab vedotin-tftv for injection) for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Source: FDA website	New Drug	09-20-21
Cefazolin IntegraDose Compounding Services announced a voluntary recall of nine lots of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/integradose-compounding-services-llc-issues-voluntary-nationwide-recall-cefazolin-injection-products?utm_medium=email&utm_source=govdelivery Source: FDA website	Drug Recall	09-22-21
Repatha The Food and Drug Administration (FDA) approved Repatha® (evolocumab injection) as an add-on treatment to diet alone or together with certain other therapies for individuals aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). Source: FDA website	New Indication	09-24-21
Erbitux The Food and Drug Administration (FDA) approved Erbitux® (cetuximab injection) in combination with Braftovi® (encorafenib capsules) for the treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation, as detected by a Food and Drug Administration (FDA)-approved test, after prior therapy. Source: FDA website	New Indication	09-24-21
Qulipta The Food and Drug Administration (FDA) approved Qulipta™ (atogepant tablets) for the preventive treatment of episodic migraine in adults. Source: FDA website	New Drug	09-28-21
Livmarli The Food and Drug Administration (FDA) approved Livmarli™ (maralixibat oral solution) for the treatment of cholestatic pruritus in individuals with Alagille syndrome one year of age and older. Source: FDA website	New Drug	09-29-21
Glucagon Eli Lilly and Company announced a voluntary recall of one lot of Glucagon™ (glucagon for injection) Emergency Kit due to a report that the vial was in liquid form instead of the powder form. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eli-lilly-and-company-issues-voluntary-nationwide-recall-one-lot-glucagonr-emergency-kit-due-loss Source: FDA website	Drug Recall	09-27-21
Tecartus The Food and Drug Administration (FDA) approved Tecartus® (brexucabtagene autoleucel injection) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website	New Indication	10-01-21
Zercapli The Food and Drug Administration (FDA) approved Zercapli (sertraline hydrochloride capsules) for the treatment of major depressive disorder in adults and for the treatment of obsessive-compulsive disorder in adults and pediatric individuals 6 years and older. Source: FDA website	New Indication	10-04-21
Tavneos The Food and Drug Administration (FDA) approved Tavneos™ (avacopan capsules) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. Source: FDA website	New Drug	10-08-21
Dextenza The Food and Drug Administration (FDA) approved Dextenza� (dexamethasone intraocular suspension) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website	New Indication	10-11-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda� (pembrolizumab injection) ) in combination with chemotherapy, with or without bevacizumab, for individuals with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death ligand-1 (PD-L1) combined positive score (CPS)�=1, as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website	New Indication	10-13-21
Verzenio The Food and Drug Administration (FDA) approved Verzenio� (abemaciclib tablets) approved in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of =20% as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website	Expanded Indication	10-12-21
Tecentriq The Food and Drug Administration (FDA) approved Tecentriq� (atezolizumab injection) for adjuvant treatment following resection and platinum-based chemotherapy in individuals with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have programmed death ligand-1 (PD-L1) expression on =�1%�of tumor cells, as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website	Expanded Indication	10-15-21
Biktarvy The Food and Drug Administration (FDA) approved Biktarvy� (bictegravir/ emtricitabine/tenofovir alafenamide tablets) to include treatment of human immunodeficiency virus (HIV)-1 infected pediatric individuals weighing at least 14 kg. Source: FDA website	Expanded Indication	10-07-21
Rethymic The Food and Drug Administration (FDA) approved Rethymic� (allogeneic processed thymus tissue-agdc surgical implant) for immune reconstitution in children with congenital athymia. Source: FDA website	New Drug	10-08-21
Lidocaine 4% Teligent Pharma announced a voluntary recall of 5 lots of Lidocaine 4% topical solution due to super potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-worldwide-voluntary-recall-lidocaine-hcl-topical-solution-4-due-super Source: FDA website	Drug Recall	10-13-21
Irbesartan; Irbesartan/Hydrochlorothiazide Lupin Pharmaceuticals announced a voluntary recall of all batches of irbesartan tablets and irbesartan/hydrochlorothiazide tablets due to the potential presence of N-nitrosoirbesartan impurity. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-all-irbesartan-tablets-and-irbesartan Source: FDA website	Drug Recall	10-14-21
Flucelvax Quadrivalent The Food and Drug Administration (FDA) approved Flucelvax® Quadrivalent (influenza vaccine injection) for active immunization in individuals 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website	Expanded Indication	10-15-21
Vimpat The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablet, oral solution, and injection) for monotherapy and adjunctive therapy in the treatment of partial onset seizures in individuals 1 month and older to less than 4 years of age. Source: FDA website	Expanded Indication	10-14-21
Zimhi The Food and Drug Administration (FDA) approved ZimhiTM (naloxone injection) for use in the treatment of opioid overdose. Source: FDA website	New Formulation	10-15-21
Seglentis The Food and Drug Administration (FDA) approved Seglentis (celecoxib/tramadol tablets) for the treatment of acute pain in adults. Source: FDA website	New Formulation	10-18-21
Tyrvaya The Food and Drug Administration (FDA) approved TyrvayaTM (varenicline nasal spray) for the treatment of the signs and symptoms of dry eye disease. Source: FDA website	New Drug	10-15-21
Methocarbamol Bryant Ranch Prepack announced a voluntary recall of one lot of methocarbamol 500 mg due to mislabeling with the incorrect strength. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-methocarbamol-500mg-bottles-due-mislabeling Source: FDA website	Drug Recall	10-19-21
Dupixent The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for add-on maintenance treatment in moderate-to-severe asthma in children ages 6 to 11 years. Source: FDA website	Expanded Indication	10-20-21
Cutaquig The Food and Drug Administration (FDA) approved Cutaquig® (human immune globulin subcutaneous injection) in pediatric individuals 2 years of age and older for the treatment of primary humoral immunodeficiency. Source: FDA website	Expanded Indication	10-22-21
Susvimo The Food and Drug Administration (FDA) approved SusvimoTM (ranibizumab injection) for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Source: FDA website	New Formulation	10-22-21
Xipere The Food and Drug Administration (FDA) approved XipereTM (triamcinolone acetonide injection for suprachoroidal use) for the treatment of macular edema associated with uveitis. Source: FDA website	New Formulation	10-22-21
Vuity The Food and Drug Administration (FDA) approved VuityTM (pilocarpine 1.25% ophthalmic solution) for the treatment of presbyopia in adults. Source: FDA website	New Formulation	10-28-21
Purified Cortrophin Gel The Food and Drug Administration (FDA) approved Purified Cortrophin® Gel (repository corticotropin injection) for the treatment of rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic disease, respiratory diseases, edematous states, and acute exacerbation of multiple sclerosis. Source: FDA website	New Formulation	11-01-21
Scemblix The Food and Drug Administration (FDA) approved Scemblix® (asciminib tablets) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) and for the treatment of adults with Ph+ CML in CP with T315I mutation. Source: FDA website	New Drug	10-29-21
Monoject Flush Prefilled Saline Syringes Aligned Medical Solutions announced a voluntary recall of Cardinal Health's MonojectTM Flush Prefilled Saline Syringes placed into kits due to the potential for the plunger to draw back after air has been expelled allowing for reintroduction of air back into the syringe. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-cardinal-healths Source: FDA website	Drug Recall	10-28-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of individuals with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Source: FDA website	New Indication	11-17-21
Dyanavel XR The Food and Drug Administration (FDA) approved Dyanavel® XR (amphetamine extended-release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website	New Formulation	11-04-21
Eprontia The Food and Drug Administration (FDA) approved EprontiaTM (topiramate oral solution) as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in individuals 2 years of age or older: adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in individuals 2 years of age and older; and preventive treatment of migraine in individuals12 years of age and older. Source: FDA website	New Formulation	11-05-21
Dhivy The Food and Drug Administration (FDA) approved DhivyTM (carbidopa/levodopa tablets) for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Source: FDA website	New Formulation	11-12-21
Besremi The Food and Drug Administration (FDA) approved Besremi® (ropeginterferon alfa-2b-njft injection) for the treatment of adults with polycythemia vera (PV). Source: FDA source	New Drug	11-12-21
Voxzogo The Food and Drug Administration (FDA) approved VoxzogoTM (vosoritide injection) to increase linear growth in pediatric individuals with achondroplasia who are 5 years of age and older with open epiphyses. Source: FDA website	New Drug	11-19-21
SterRx SterRx announced a voluntary recall of approximately 240 lots of products due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-certain-sterrx-products Source: FDA website	Drug Recall	11-16-21
Injectafer The Food and Drug Administration (FDA) approved Injectafer® (ferric carboxymaltose injection) for pediatric individuals 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron. Source: FDA website	Expanded Indication	11-19-21
Darzalex Faspro The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with carfilzomib plus dexamethasone for adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Source: FDA website	Expanded Indication	11-30-21
Lyvispah The Food and Drug Administration (FDA) approved Lyvispah (baclofen oral granules) for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Lyvispah may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Source: FDA website	New Formulation	11-22-21
Livtencity The Food and Drug Administration (FDA) approved Livtencity (maribavir tablets) for the treatment of adults and pediatric individuals (≥12 years of age and weighing ≥35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. Source: FDA website	New Drug	11-23-21
Fyarro The Food and Drug Administration (FDA) approved Fyarro™ (sirolimus protein-bound particles for injectable suspension) for the treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), Source: FDA website	New Drug	11-22-21
PreHevbrio The Food and Drug Administration (FDA) approved PreHevbrio™ (recombinant hepatitis B vaccine injection) for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. Source: FDA website	New Vaccine	12-01-21
Rituxan The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) approved in combination with chemotherapy for pediatric individuals (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Source: FDA website	New Indication	12-02-21
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of adult and pediatric (12 years and older) individuals with stage IIB or IIC melanoma following complete resection. Additionally, the Food and Drug Administration (FDA) expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric individuals (12 years and older). Source: FDA website	New Indication	12-03-21
Siklos The Food and Drug Administration (FDA) approved Siklos® (hydroxyurea tablets) to include adults to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric individuals, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website	New Indication	12-07-21
Zynrelef The Food and Drug Administration (FDA) approved Zynrelef® (bupivacaine/meloxicam extended-release solution for soft tissue or periarticular instillation) in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Source: FDA website	Expanded Indication	12-08-21
Xaciato The Food and Drug Administration (FDA) approved XaciatoTM (clindamycin phosphate vaginal gel) for the treatment of bacterial vaginosis in females 12 years of age and older. Source: FDA website	New Formulation	12-07-21
Enoxaparin sodium Sandoz announced a voluntary recall of one lot of enoxaparin sodium injection due to temperature excursion during shipment. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-one-lot-enoxaparin-sodium-injection-usp-40mg04-ml-due Source: FDA website	Drug Recall	12-03-21
Zepatier The Food and Drug Administration (FDA) approved ZepatierTM (elbasvir/grazoprevir tablets) for the treatment of individuals aged 12 to less than 18 years with chronic hepatitis C (HCV) genotype 1 or 4 infection without cirrhosis. Source: FDA website	Expanded Indication	12-09-21
Oxbryta The Food and Drug Administration (FDA) approved Oxbryta® (voxelotor tablets and tablets for oral suspension) to treat sickle cell disease in pediatric individuals aged four up to 11 years. Source: FDA website	Expanded Indication/New Dosage Form	12-17-21
Rinvoq The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with active psoriatic arthritis who have had an inadequate response, or intolerance to, tumor necrosis factor (TNF) inhibitors. Source: FDA website	New Indication	12-14-21
Xeljanz/Xeljanz XR The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) and Xeljanz® XR (tofacitinib extended-release tablets) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website	New Indication	12-14-21
Orencia The Food and Drug Administration (FDA) approved Orencia® (abatacept injection) for the prophylaxis of acute graft-versus-host disease (aGVHD) in combination with certain immunosuppressants. Source: FDA website	New Indication	12-15-21
Entadfi The Food and Drug Administration (FDA) approved EntadfiTM (finasteride/tadalafil capsules) for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks. Source: FDA website	New Formulation	12-09-21
Tarpeyo The Food and Drug Administration (FDA) approved TarpeyoTM (budesonide delayed-release capsules) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. Source: FDA website	New Formulation	12-15-21
Clozapine The Food and Drug Administration (FDA) authorizes enforcement discretion to temporarily ease certain requirements of the clozapine risk evaluation and mitigation strategy (REMS) to help ensure continuity of care. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program?utm_medium=email&utm_source=govdelivery Source: FDA website	Drug Warning	12-16-21
Xarelto The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets and oral suspension) to treat venous thromboembolism (VTE) and to reduce the risk of VTE recurring in pediatric individuals from birth to younger than 18 years who have received at least five days of injectable or intravenous treatment for blood clots. It was also approved to prevent blood clots in pediatric individuals two years and older with congenital heart disease after the Fontan procedure, a type of open-heart surgery. Source: FDA website	Expanded Indication/New Dosage Form	12-20-21
Otezla The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of adults with plaque psoriasis who are candidates for phototherapy or systemic therapy, regardless of severity level. Source: FDA website	Expanded Indication	12-20-21
Caplyta The Food and Drug Administration (FDA) approved Caplyta® (lumateperone capsules) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Source: FDA website	New Indication	12-17-21
Vocabria The Food and Drug Administration (FDA) approved Vocabria (cabotegravir sodium tablets) as oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension for human immunodeficiency (HIV)-1 pre-exposure prophylaxis (PrEP) and oral therapy for individuals who will miss planned injection dosing with cabotegravir injectable for HIV-1 PrEP.Source: FDA website	New Indication	12-20-21
Cosentyx The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of active enthesitis-related arthritis (ERA) in individuals four years and older and active psoriatic arthritis (PsA) in individuals two years and older. Source: FDA website	New Indication	12-22-21
Dartisla ODT The Food and Drug Administration (FDA) approved Dartisla ODT (glycopyrrolate orally disintegrating tablets) in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Source: FDA website	New Formulation	12-16-21
Apretude The Food and Drug Administration (FDA) approved Apretude (cabotegravir extended-release injectable suspension) in at-risk adults and adolescents weighing at least 35 kg for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). Source: FDA website	New Formulation	12-20-21
Leqvio The Food and Drug Administration (FDA) approved Leqvio® (inclisiran injection) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Source: FDA website	New Drug	12-22-21
Vyvgart The Food and Drug Administration (FDA) approved VyvgartTM (efgartigimod alfa-fcab injection) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. Source: FDA website	New Drug	12-17-21
Tezspire The Food and Drug Administration (FDA) approved TezspireTM (tezepelumab-ekko injection) as add-on maintenance treatment of adult and pediatric individuals aged 12 years and older with severe asthma. Source: FDA website	New Drug	12-17-21
Rexulti The Food and Drug Administration (FDA) approved Rexulti® (brexpiprazole tablets) for the treatment of schizophrenia in individuals aged 13 to 17 years. Source: FDA website	Expanded Indication	12/27/2021
Tascenso ODT The Food and Drug Administration (FDA) approved Tascenso ODTTM (fingolimod lauryl sulfate orally disintegrating tablets) for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in pediatric individuals 10 years of age and older and weighing less than or equal to 40 kg. Source: FDA website	New Formulation	12/23/2021
Adbry The Food and Drug Administration (FDA) approved AdbryTM (tralokinumab-ldrm injection) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website	New Drug	12/27/2021
Recorlev The Food and Drug Administration (FDA) approved Recorlev® (levoketoconazole tablets) for the treatment of adults with Cushing’s syndrome with endogenous high cortisol levels for whom surgery is not an option or has not been curative. Source: FDA website	New Drug	12/30/2021
Metformin Viona announced a voluntary recall of thirty three lots of metformin hydrochloride extended-release tablets 750 mg due to the detection of N-nitrosodimethylamine (NDMA) impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website	Drug Recall	12/29/2021
Clobetasol propionate ointment Taro Pharmaceuticals announced a voluntary recall of one lot of clobetasol propionate ointment 0.05% packaged in 60 gram tubes due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-clobetasol-propionate-ointment-usp-005 Source: FDA website	Drug Recall	12/31/2021
Nitroglycerin lingual spray Padagis announces a voluntary recall of nitroglycerin lingual spray due to a possible defective delivery system. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/padagis-issues-voluntary-nationwide-recall-nitroglycerin-lingual-spray-due-possible-defective Source: FDA website	Drug Recall	12/27/2021
Descovy The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide fumarate tablets) to include treatment of human immunodeficiency virus (HIV)-1 infection in pediatric individuals at least 2 years of age and weighing at least 14 kg.Source: FDA website	Expanded Indication	01-07-22
Quviviq The Food and Drug Administration (FDA) approved Quviviq (daridorexant tablets) for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.Source: FDA website	New Drug	01-07-22
Senna Lohxa announced a voluntary recall of one lot of Senna Syrup 8.8 mg/5 mL unit-dose cups due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination Source: FDA website	Drug Recall	01-13-22
Metformin Viona Pharmaceuticals announced a voluntary recall of twenty-three lots of metformin hydrochloride extended-release tablets 750 mg due to detection of N-nitrosamine (NDMA) impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website	Drug Recall	01-12-22
Buprenorphine The Food and Drug Administration (FDA) is warning that dental problems (tooth decay, cavities, oral infection, and loss of teeth) have been reported with medicines containing buprenorphine that are dissolved in the mouth for opioid use disorder and pain. The FDA is requiring a new warning be added to the prescribing information. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines Source: FDA website	Drug Warning	01-12-22
Rinvoq The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib tablets) for the treatment of adults and children 12 years of age and older with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website	New Indication	01-14-22
Skyrizi The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website	New Indication	01-24-22
Veklury The Food and Drug Administration (FDA) approved Veklury® (remdesivir injection) for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Source: FDA website	Expanded Indication	01-21-22
Ryaltris The Food and Drug Administration (FDA) approved RyaltrisTM (olopatadine hydrochloride/mometasone furoate nasal spray) for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric individuals 12 years of age and older. Source: FDA website	New Formulation	01-13-22
Cibinqo The Food and Drug Administration (FDA) approved CibinqoTM (abrocitinib tablets) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website	New Drug	01-14-22
Semglee Mylan Pharmaceuticals announced a voluntary recall of one batch of its non-interchangeable Semglee injection due to the potential for a missing label. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin Source: FDA website	Drug Recall	01-19-22
Solosec The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules) for the treatment of bacterial vaginosis and trichomoniasis caused by Trichomonas vaginalis in individuals 12 years of age and older. Source: FDA website	Expanded Indication	01-26-22
Pifeltro The Food and Drug Administration (FDA) approved Pifeltro® (doravirine tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website	Expanded Indication	01-27-22
Delstrigo The Food and Drug Administration (FDA) approved DelstrigoTM (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website	Expanded Indication	01-27-22
Vonvendi The Food and Drug Administration (FDA) approved Vonvendi® (recombinant von Willebrand factor injection) for routine prophylaxis to reduce the frequency of bleeding episodes in individuals with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy. Source: FDA website	Expanded Indication	01-31-22
Nucala The Food and Drug Administration (FDA) approved Nucala (mepolizumab 40 mg prefilled syringe injection) as add-on maintenance treatment for children 6 to 11 years of age with severe asthma and with an eosinophilic phenotype. Source: FDA website	New Formulation	01-22-22
Kimmtrak The Food and Drug Administration (FDA) approved Kimmtrak® (tebentafusp-tebn injection) for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). Source: FDA website	New Drug	01-26-22
Vabysmo The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa injection for intravitreal use) for the treatment of adults with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Source: FDA website	New Drug	01-28-22
Polymyxin B AuroMedics Pharma announced a voluntary recall of one lot of polymyxin B for injection due to a product complaint for the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial Source: FDA website	Drug Recall	01-28-22
Xigduo XR The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin hydrochloride extended-release tablets) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Source: FDA website	New Indication	02-03-22
Fleqsuvy The Food and Drug Administration (FDA) approved FleqsuvyTM (baclofen oral suspension) for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Source: FDA website	New Formulation	02-04-22
Enjaymo The Food and Drug Administration (FDA) approved EnjaymoTM (sutimlimab-jome injection) to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Source: FDA website	New Drug	02-04-22
Ukoniq The Food and Drug Administration (FDA) is investigating a possible increased risk of death due to the cancer drug Ukoniq® (umbralisib tablets). The FDA is re-evaluating the risk versus benefit of Ukoniq and is continuing to look at results from the UNITY clinical trial. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-investigating-possible-increased-risk-death-lymphoma Source: FDA website	Drug Warning	02-03-22
Jardiance The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) to treat adults with heart failure regardless of left ventricular ejection fraction. Source: FDA website	Expanded Indication	02-24-22
Norliqva The Food and Drug Administration (FDA) approved Norliqva® (amlodipine oral solution) for the treatment of hypertension in adults and children 6 years and older and for the treatment of coronary artery disease and angiographically documented coronary artery disease in individuals without heart failure or an ejection fraction <40%. Source: FDA website	New Formulation	02-24-22
Aspruzyo Sprinkle The Food and Drug Administration (FDA) approved Aspruzyo SprinkleTM (ranolazine extended-release oral granules) for the treatment of chronic angina. Source: FDA website	New Formulation	02-28-22
Pyrukynd The Food and Drug Administration (FDA) approved Pyrukynd® (mitapivat tablets) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Source: FDA website	New Drug	02-17-22
Carvykti The Food and Drug Administration (FDA) approved CarvyktiTM (ciltacabtagene autoleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Source: FDA website	New Drug	02-28-22
Vonjo The Food and Drug Administration (FDA) approved VonjoTM (pacritinib capsules) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Source: FDA website	New Drug	02-28-22
Opdivo The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with platinum-doublet chemotherapy for adults with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. Source: FDA website	Expanded Indication	03-04-22
Lynparza The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Source: FDA website	Expanded Indication	03-11-22
Keytruda The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as a single agent for individuals with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by a Food and Drug Administration (FDA)-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. Source: FDA website	Expanded Indication	03-21-22
Smoflipid The Food and Drug Administration (FDA) approved Smoflipid® (lipid injectable emulsion) as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated expanded to include pediatric individuals. Source: FDA website	Expanded Indication	03-22-22
Rinvoq The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website	New Indication	03-16-22
Adlarity The Food and Drug Administration (FDA) approved Adlarity® (donepezil transdermal system) for the treatment of adults with mild, moderate, and severe dementia of the Alzheimer type. Source: FDA website	New Formulation	03-11-22
Xelstrym The Food and Drug Administration (FDA) approved XelstrymTM (dextroamphetamine transdermal system) for the treatment of attention-deficit/hyperactivity disorder (ADHD) for adults and pediatric individuals 6 years and older. Source: FDA website	New Formulation	03-23-22
Hyftor The Food and Drug Administration (FDA) approved HyftorTM (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric individuals 6 years of age and older. Source: FDA website	New Formulation	03-22-22
Ztalmy The Food and Drug Administration (FDA) approved Ztalmy® (ganaxolone oral suspension) for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in individuals 2 years of age or older. Source: FDA website	New Drug	03-18-22
Opdualag The Food and Drug Administration (FDA) approved OpdualagTM (nivolumab/relatlimab-rmbw injection) for the treatment of adult and pediatric individuals 12 years of age or older with unresectable or metastatic melanoma. Source: FDA website	New Drug	03-18-2022
Pluvicto The Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan injection) for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Source: FDA website	New Drug	03-23-22
Sodium acetate Fresenius Kabi announced a voluntary recall of seven lots of sodium acetate injection due to the presence of particulate matter.Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-recall-sodium-acetate-injection-usp-due-presence-particulate-matter Source: FDA website	Drug Recall	03-08-22
Quinapril/hydrochlorothiazide Pfizer announced a voluntary recall of six lots of AccureticTM (quinapril HCL/hydrochlorothiazide) tablets distributed by Pfizer as well as five lots of two authorized generics distributed by Greenstone due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and Source: FDA website	Drug Recall	03-22-22
Orphenadrine citrate Sandoz announced a voluntary recall of 13 lots of oral orphenadrine citrate 100 mg extended-release tablets due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due Source: FDA website	Drug Recall	03-23-22
Symjepi Adamis Pharmaceuticals announced a voluntary recall of certain lots of SymjepiTM (epinephrine injection) due to the potential clogging of the needle preventing the dispensing of epinephrine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection Source: FDA website	Drug Recall	03-22-22
Fintepla The Food and Drug Administration (FDA) approved Fintepla® (fenfluramine oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome in individuals two years of age and older. Source: FDA website	New Indication	03-25-22
Cabenuva The Food and Drug Administration (FDA) approved Cabenuva (cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension) for expanded use of every 2-month dosing regimen to include the treatment of human immunodeficiency virus (HIV)-1 infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website	Expanded Indication	03-29-22
Vocabria and Edurant The Food and Drug Administration (FDA) approved Vocabria (cabotegravir tablets) for expanded use in combination with Edurant® (rilpivirine tablets) as an oral, short-term treatment regimen followed by Cabenuva injection dosing regimen for the treatment of human immunodeficiency virus (HIV)-1 virus infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website	Expanded Indication	03-29-22
Tlando The Food and Drug Administration (FDA) approved TlandoTM (testosterone undecanoate oral capsule) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website	New Formulation	03-28-22
Triumeq PD The Food and Drug Administration (FDA) approved Triumeq PD (abacavir/dolutegravir/lamivudine dispersible tablets for oral suspension) for the treatment of pediatric individuals weighing 10 kg to < 25 kg with human immunodeficiency virus type 1 (HIV-1). The original tablet formulation of Triumeq was also expanded to individuals weighing at least 10 kg. Source: FDA website	New Formulation	03-30-22
Idarubicin Teva Pharmaceuticals announced a voluntary recall of one lot of idarubicin hydrochloride injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due Source: FDA website	Drug Recall	03-30-22
North American Custom Laboratories The Food and Drug Administration (FDA) issued a warning not to use products intended to be sterile produced by North American Custom Laboratories due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom?utm_medium=email&utm_source=govdelivery Source: FDA website	Drug Warning	03-31-22
Iodine-containing contrast media The Food and Drug Administration (FDA) approved a new warning to the prescribing label for the entire class of iodinated contrast media injections and monitoring recommendations for children 3 years or younger. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/iodine-containing-contrast-media-drug-safety-communication-fda-recommends-thyroid-monitoring-babies Source: FDA website	Drug Warning	03-31-22
Yescarta The Food and Drug Administration (FDA) approved Yescarta® (axicabtagene ciloleucel for intravenous infusion) for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. Source: FDA website	Expanded Indication	04-01-22
Igalmi The Food and Drug Administration (FDA) approved IgalmiTM (dexmedetomidine sublingual film) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Source: FDA website	New Formulation	04-05-22
Vijoice The Food and Drug Administration (FDA) approved Vijoice® (alpelisib tablets) for the treatment of adult and pediatric individuals 2 years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Source: FDA website	New Formulation	04-05-22
Xigduo XR The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin extended-release tablet) to reduce the risk of sustained estimated glomerular filtration rate decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Source: FDA website	Expanded Indication	04-11-22
Insulin glargine Mylan Pharmaceuticals announced a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin Source: FDA website	Drug Recall	04-13-22
Zerbaxa The Food and Drug Administration (FDA) approved Zerbaxa® (ceftolozane sulfate/tazobactam sodium injection) in pediatric individuals from birth to less than 18 years of age for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI). Source: FDA website	Expanded Indication	04-21-22
Ultomiris The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab-cwvz injection) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Source: FDA website	New Indication	04-27-22
Epsolay The Food and Drug Administration (FDA) approved Epsolay® (benzoyl peroxide cream) for the treatment of inflammatory lesions of rosacea in adults. Source: FDA website	New Formulation	04-22-22
Cuvrior The Food and Drug Administration (FDA) approved CuvriorTM (trientine tetrahydrochloride tablets) for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine. Source: FDA website	New Formulation	04-28-22
Vivjoa The Food and Drug Administration (FDA) approved VivjoaTM (oteseconazole capsules) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. Source: FDA website	New Drug	04-27-22
Camzyos The Food and Drug Administration (FDA) approved CamzyosTM (mavacamten capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Source: FDA website	New Drug	04-28-22
Accupril Pfizer announced a voluntary recall of five lots of Accupril due to the presence of a nitrosamine above the acceptable level. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content Source: FDA website	Drug Recall	04-23-22
Rinvoq The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website	New Indication	04-29-22
Olumiant The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Source: FDA approval	New Indication	05-10-22
Qelbree The Food and Drug Administration (FDA) approved Qelbree® (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults aged 18 and older. Source: FDA website	Expanded Indication	05-02-22
Enhertu The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for the treatment of adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. Source: FDA website	Expanded Indication	05-04-22
Ermeza The Food and Drug Administration (FDA) approved ErmezaTM (levothyroxine sodium oral solution) in adult and pediatric individuals, including neonates, as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Also approved as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Source: FDA website	New Formulation	04-29-22
Radicava ORS The Food and Drug Administration (FDA) approved Radicava ORS® (edaravone oral suspension) for the treatment of adults with amyotrophic lateral sclerosis (ALS). Source: FDA website	New Formulation	05-12-22
Mounjaro The Food and Drug Administration (FDA) approved MounjaroTM (tirzepatide subcutaneous injection) to improve blood sugar control in adults with type 2 diabetes as an addition to diet and exercise. Source: FDA website	New Drug	05-12-22
Voquezna Triple Pak and Voquezna Dual Pak The Food and Drug Administration (FDA) approved VoqueznaTM Triple PakTM (vonoprazan tablets/amoxicillin capsules/ clarithromycin tablets co-packaged for oral use) and VoqueznaTM Dual PakTM (vonoprazan tablets/amoxicillin capsules/co-packaged for oral use) for the treatment of Helicobacter pylori (H. pylori) infection in adults. Source: FDA website	New Drug	05-03-22
Dupixent The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) to treat eosinophilic esophagitis (EoE) in adults and pediatric individuals 12 years and older weighing at least 40 kg. Source: FDA website	New Indication	05-20-22
Vidaza The Food and Drug Administration (FDA) approved Vidaza® (azacitidine injection) for pediatric individuals with newly diagnosed juvenile myelomonocytic leukemia. Source: FDA website	New Indication	05-20-22
Tibsovo The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablet) in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Source: FDA website	Expanded Indication	05-25-22
TPOXX The Food and Drug Administration (FDA) approved TPOXX® (tecovirimat intravenous) for the treatment of human smallpox disease in adults and pediatric individuals weighing at least 3 kg. Source: FDA website	New Formulation	05-18-22
Tyvaso DPI The Food and Drug Administration (FDA) approved Tyvaso DPI™ (treprostinil oral inhalation) for the treatment of individuals with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Source: FDA website	New Formulation	05-23-22
Vtama The Food and Drug Administration (FDA) approved Vtama® (tapinarof topical cream) for the treatment of plaque psoriasis in adults. Source: FDA website	New Drug	05-24-22
Anagrelide Teva Pharmaceuticals announced a voluntary recall of a single lot of anagrelide capsules due to dissolution test failure. Contact your healthcare provider with details. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test Source: FDA website	Drug Recall	05-23-22
Evrysdi The Food and Drug Administration (FDA) approved Evrysdi® (risdiplam oral solution) to include treatment of infants under 2 months old with spinal muscular atrophy (SMA). Source: FDA website	Expanded Indication	05-27-22
Opdivo The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab injection) as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of programmed death-ligand 1 (PD-L1) status. Source: FDA website	Expanded Inciation	05-27-22
Kymriah The Food and Drug Administration (FDA) approved Kymriah® (tisagenlecleucel injection) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website	Expanded Inciation	05-28-22
Beovu The Food and Drug Administration (FDA) approved Beovu® (brolucizumab-dbll) for the treatment of diabetic macular edema (DME). Source: FDA website	New Indication	05-27-22
Ukoniq The Food and Drug Administration (FDA) has withdrawn approval for the cancer medication UkoniqTM (umbralisib tablet) due to safety concerns. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-approval-lymphoma-medicine-withdrawn-due-safety Source: FDA website	Drug Warning	06-01-22
CellCept The Food and Drug Administration (FDA) approved CellCept® (mycophenolate mofetil capsule, tablet, oral suspension, and injection) for the prophylaxis of organ rejection in pediatric recipients of allogenic heart and allogenic liver transplants aged 3 months and older in combination with other immunosuppressants. Source: FDA website	Expanded Indication	06-06-22
Dupixent The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for when those therapies are not advisable. Source: FDA website	Expanded Indication	06-07-22
Priorix The Food and Drug Administration (FDA) approved Priorix (measles, mumps, and rubella vaccine, live suspension for subcutaneous injection) for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. Source: FDA website	New Formulation	06-03-22
Olumiant The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of adults with severe alopecia areata. Source: FDA website	New Indication	06-13-22
Imcivree The Food and Drug Administration (FDA) approved ImcivreeTM (setmelanotide subcutaneous injection) for chronic weight management in adult and pediatric individuals 6 years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). Source: FDA website	New Indication	06-16-22
Skyrizi The Food and Drug Administration (FDA) approved Skyrizi® (risankizumab-rzaa injection) for the treatment of adults with moderately to severely active Crohn's disease. Source: FDA website	New Indication	06-17-22
Amvuttra The Food and Drug Administration (FDA) approved AmvuttraTM (vutrisiran subcutaneous injection) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Source: FDA website	New Drug	06-13-22
Zulresso The Food and Drug Administration (FDA) approved ZulressoTM (brexanolone injection for intravenous use) for expansion to include individuals 15 years and older diagnosed with postpartum depression. Source: FDA website	Expanded Indication	06-16-22
Vaxneuvance The Food and Drug Administration (FDA) approved VaxneuvanceTM (pneumococcal 15-valent conjugate vaccine intramuscular injection) expanded for active immunization for the prevention of invasive disease caused by certain Streptococcus pneumoniae serotypes in individuals 6 weeks of age and older. Source: FDA website	Expanded Indication	06-22-22
Mekinist plus Tafinlar The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) plus Tafinlar® (dabrafenib capsules) for the treatment of adult and pediatric individuals 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Source: FDA website	Expanded Indication	06-22-22
Breyanzi The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel suspension for intravenous infusion) for the treatment of adults with large B-cell lymphoma (LBCL) after one prior therapy. Source: FDA website	Expanded Indication	06-24-22
Qsymia The Food and Drug Administration (FDA) approved Qsymia® (phentermine/topiramate extended-release capsules) for chronic weight management in pediatric individuals aged 12 years and older who are obese, defined as a body mass index (BMI) of 95th percentile or greater when standardized for age and sex. Source: FDA website	Expanded Indication	06-24-22
Morphine sulfate Bryant Ranch Prepack announced a voluntary recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets due to incorrect labeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release Source: FDA website	Drug Recall	06-29-22
Kyprolis The Food and Drug Administration (FDA) approved Kyprolis® (carfilzomib injection) in combination with Sarclisa® (isatuximab-irfc injection) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received one to three lines of therapy. Source: FDA website	Expanded Indication	06-30-22
Krystexxa The Food and Drug Administration (FDA) approved Krystexxa® (pegloticase injection) for concomitant use with methotrexate for the treatment of individuals with uncontrolled gout to achieve a complete response to therapy. Source: FDA website	Expanded Indication	07-07-22
Drospirenone The Food and Drug Administration (FDA) approved Drospirenone chewable tablets for use by females of reproductive potential to prevent pregnancy. Source: FDA website	New Formulation	09-29-22
Venbysi XR The Food and Drug Administration (FDA) approved Venbysi XR (venlafaxine besylate extended-release oral tablets) for the treatment of major depressive disorder and generalized anxiety disorder in adults. Source: FDA website	New Formulation	09-29-22
Insulin glargine Mylan Pharmaceuticals announced a voluntary recall of one batch of insulin glargine injection due to the potential of missing labels on some pens. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-issues-voluntary-nationwide-recall-one-batch-insulin Source: FDA website	Drug Recall	07-06-22
Copiktra The Food and Drug Administration (FDA) is warning that results from a clinical trial show a possible increased risk of death and serious adverse events with the oncology medicine Copiktra® (duvelisib capsules). The FDA will continue to evaluate the safety of this agent. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/copiktra-duvelisib-drug-safety-communication-fda-warns-about-possible-increased-risk-death-and Source: FDA website	Drug Warning	06-30-22
Xalkori The Food and Drug Administration (FDA) approved Xalkori® (crizotinib capsules) for adult and pediatric individuals 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). Source: FDA website	New Indication	07-14-22
Opzelura The Food and Drug Administration (FDA) approved Opzelura™ (ruxolitinib cream) for the topical treatment of nonsegmental vitiligo in adult and pediatric individuals 12 years of age and older. Source: FDA website	New Indication	07-18-22
Diacomit The Food and Drug Administration (FDA) approved Diacomit® (stiripentol capsules) for the treatment of seizures associated with Dravet syndrome (DS) in individuals taking clobazam who are 6 months of age and older and weighing 7 kg or more. Source: FDA website	Expanded Indication	07-14-22
Zonisade The Food and Drug Administration (FDA) approved Zonisade™ (zonisamide oral suspension) as adjunctive therapy for the treatment of partial onset seizures in adults and pediatric individuals 16 years of age and older. Source: FDA website	New Formulation	07-15-22
Benlysta The Food and Drug Administration (FDA) approved Benlysta® (belimumab injection) to include pediatric individuals 5 to 17 years of age with active lupus nephritis who are receiving standard therapy. Source: FDA website	Expanded Indication	07-26-22
Stelara The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) to include the treatment of pediatric individuals 6 years and older with active psoriatic arthritis. Source: FDA website	Expanded Indication	07-29-22
Rebinyn The Food and Drug Administration (FDA) approved Rebinyn® (coagulation factor IX, recombinant injection) to include use in adults and children with hemophilia B for routine prophylaxis to reduce the frequency of bleeding episodes. Source: FDA website	Expanded Indication	08-1-22
Tadliq The Food and Drug Administration (FDA) approved Tadliq® (tadalafil oral suspension) for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Source: FDA website	New Formulation	06-17-22
Ultomiris The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab-cwvz subcutaneous on-body injection) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Source: FDA website	New Formulation	07-22-22
Kyzatrex The Food and Drug Administration (FDA) approved Kyzatrex® (testosterone undecanoate oral capsules) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website	New Formulation	07-27-22
Zoryve The Food and Drug Administration (FDA) approved ZoryveTM (roflumilast topical) for topical treatment of plaque psoriasis, including intertriginous areas, in individuals 12 years of age and older. Source: FDA website	New Formulation	07-29-22
Magnesium citrate Vi-Jon announced a voluntary recall for all lots of all flavors of Magnesium citrate saline laxative oral solution due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-nationwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate Source: FDA website	Drug Recall	07-28-22
Enhertu The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH ) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Source: FDA website	Expanded Indication	08-05-22
Nubeqa The Food and Drug Administration (FDA) approved Nubeqa® (darolutamide tablets) in combination with docetaxel for adults with metastatic hormone-sensitive prostate cancer (mHSPC). Source: FDA website	Expanded Indication	08-05-22
Xofluza The Food and Drug Administration (FDA) approved Xofluza® (baloxavir marboxil tablets and oral suspension) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza. Source: FDA website	Expanded Indication	08-11-22
Enhertu The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by a Food and Drug Administration (FDA)-approved test, and who have received a prior systemic therapy. Source: FDA website	New Indication	08-11-22
Myfembree The Food and Drug Administration (FDA) approved Myfembree® (relugolix, estradiol, and norethindrone acetate tablets) for the treatment of endometriosis-associated pain. Source: FDA website	New Indication	08-05-22
Calquence The Food and Drug Administration (FDA) approved Calquence® (acalabrutinib tablets) for adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and for individuals with relapsed or refractory mantle cell lymphoma (MCL). Source: FDA website	New Formulation	08-03-22
Magnesium citrate Vi-Jon expanded a voluntary recall of all flavors and lots within expiry of magnesium citrate saline laxative oral solution due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vi-jon-llc-expands-voluntary-worldwide-recall-all-flavors-and-lots-within-expiry-magnesium-citrate Source: FDA website	Drug Recall	08-04-22
Milk of Magnesia and Magnesium hydroxide/aluminum hydroxide/simethicone Plastikon Healthcare expanded a voluntary recall of Milk of Magnesia oral suspension and Magnesium hydroxide/aluminum hydroxide/simethicone oral suspension due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/plastikon-healthcare-expands-voluntary-nationwide-recall-milk-magnesia-oral-suspension-and-magnesium Source: FDA website	Drug Recall	08-03-22
Imbruvica The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib tablets, capsules, and oral suspension) for pediatric individuals ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Source: FDA website	New Indication	08-24-22
Pemazyre The Food and Drug Administration (FDA) approved PemazyreTM (pemigatinib tablets) for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms or MLNs with fibroblast growth factor receptor 1 (FGFR1) rearrangement. Source: FDA website	New Indication	08-26-22
Imfinzi The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) in combination with gemcitabine and cisplatin for adults with locally advanced or metastatic biliary tract cancer (BTC). Source: FDA website	New Indication	09-02-22
Orkambi The Food and Drug Administration (FDA) approved Orkambi® (ivacaftor/lumacaftor tablets and oral granules) to include the treatment of cystic fibrosis (CF) in individuals 1 to less than 2 years of age who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Source: FDA website	Expanded Indication	09-02-22
Konvomep The Food and Drug Administration (FDA) approved KonvomepTM (omeprazole/sodium bicarbonate oral suspension) for short-term treatment (4 to 8 weeks) of active benign gastric ulcer and reduction of risk of upper gastrointestinal bleeding in critically ill adults. Source: FDA website	New Formulation	08-30-22
Xenpozyme The Food and Drug Administration (FDA) approved XenpozymeTM (olipudase alfa-rpcp injection) for the treatment of non–central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adults and pediatrics. Source: FDA website	New Drug	08-31-22
Spevigo The Food and Drug Administration (FDA) approved Spevigo® (spesolimab-sbzo injection) for the treatment of generalized pustular psoriasis flares in adults. Source: FDA website	New Drug	09-01-22
Daxxify The Food and Drug Administration (FDA) approved DaxxifyTM (daxibotulinumtoxinA-lanm injection) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. Source: FDA website	New Formulation	09-07-22
Terlivaz The Food and Drug Administration (FDA) approved Terlivaz® (terlipressin injection) to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Source: FDA website	New Drug	09-14-22
Rolvedon The Food and Drug Administration (FDA) approved RolvedonTM (eflapegrastim-xnst injection) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Source: FDA website	New Drug	09-09-22
Sotyktu The Food and Drug Administration (FDA) approved SotyktuTM (deucravacitinib oral tablets) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website	New Drug	09-09-22