Drug Information

The Food and Drug Administration (FDA) approved Tazverik^TM (tazemetostat tablets) for the treatment of adults and pediatric individuals aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. Source: FDA website

Acella Pharmaceuticals announced a voluntary recall of one lot of 15 mg and one lot of 120 mg NP Thyroid® (thyroid 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-two-lots-np-thyroidr-thyroid-tablets Source: FDA website

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

The Food and Drug Administration (FDA) approved Aduhelm™ (aducanumab-avwa injection) for the treatment of Alzheimer's disease. Source: FDA website

Perrigo announced a voluntary recall of all unexpired albuterol sulfate inhalers due to possible clogging of the inhaler. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-perrigos-voluntary-albuterol-inhaler-recall#:~:text=%5B9%2F21%2F2020%5D,clogging%20of%20the%20inhaler%20resulting Source: FDA website

Amneal announced a voluntary recall of all lots of metformin hydrochloride extended-release tablets 500 and 750 mg after seven lots were tested by the Food and Drug Administration (FDA) and showed N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website

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

Torrent Pharmaceuticals announced a voluntary recall of one lot of anagrelide capsules due to dissolution test failure. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-anagrelide-capsules-usp-due Source: FDA website

Apotex announced a voluntary recall of all lots of metformin hydrochloride extended-release 500 mg tablets after one lot was tested by the Food and Drug Administration (FDA) and showed N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. 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-metformin-hydrochloride-extended-release-tablets Source: FDA website

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

The Food and Drug Administration (FDA) approved Artesunate injection to treat severe malaria in adult and pediatric individuals. Source: FDA website

AXIA Pharmaceutical announced a voluntary recall of all unused sterile 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/fusion-iv-pharmaceuticals-inc-dba-axia-pharmaceutical-issues-voluntary-nationwide-recall-all-sterile Source: FDA website

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

Eisai has decided to withdraw the weight loss drugs Belviq® (lorcaserin tablets) and Belviq XR® (lorcaserin extended-release tablets) from the market. This is based on a recently completed analysis of data from the CAMELLIA-TIMI 61 trial. The Food and Drug Administration (FDA) is advising healthcare professionals to stop prescribing lorcaserin and to contact those who have been treated with the drug. Individuals should be informed of the increased occurrence of cancer seen in the clinical trial. Source: FDA website; Eisai website

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

The Food and Drug Administration (FDA) approved Blenrep (belantamab mafodotin-blmf injection) for adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Source: FDA website

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

The Food and Drug Administration (FDA) approved Braftovi® (encorafenib capsules) in combination with cetuximab for the treatment of Brafv600E-mutant metastatic colorectal cancer (CRC) after prior therapy. Source: FDA website

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

The Food and Drug Administration (FDA) approved Brilinta® (ticagrelor tablets) to reduce the risk of a first myocardial infarction (MI) or stroke in individuals with coronary artery disease (CAD) at high risk for such events. Source: FDA website

The Food and Drug Administration (FDA) approved Bronchitol® (mannitol inhalation powder) as add-on maintenance therapy to improve pulmonary function in adults 18 years of age and older with cystic fibrosis (CF). Source: FDA website

The Food and Drug Administration (FDA) approved ByfavoTM (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Source: FDA website

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

The Food and Drug Administration (FDA) approved Camcevi® (leuprolide mesylate subcutaneous injection depot) for the treatment of advanced prostate cancer. Source: FDA website

Braun Medical Inc. announced a voluntary recall of 1 lot of ceftazidime and dextrose for injection due to out-of-specification stability test results for high molecular weight polymers. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-one-1-lot-ceftazidime-injection-usp-and Source: FDA website

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

The Food and Drug Administration (FDA) is strengthening an existing warning that constipation caused by the schizophrenia medication clozapine can progress to serious bowel complications. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/clozaril-fazaclo-odt-versacloz-clozapine-drug-safety-communication-fda-strengthens-warning-untreated Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved Cyramza® (ramucirumab injection) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Source: FDA website

The Food and Drug Administration (FDA) approved Danyelza® (naxitamab-gqgk intravenous injection) for the treatment of pediatric individuals 1 year of age and older and adults with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with Kyprolis® (carfilzomib injection) and dexamethasone for the treatment of adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. Source: FDA website

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

Denton Pharma, doing business as Northwind Pharmaceuticals, announced a voluntary recall of all unexpired lots of ranitidine tablets due to potential presence of the impurity N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/denton-pharma-inc-dba-northwind-pharmaceuticals-voluntarily-recalls-all-unexpired-lots-its Source: FDA website

Fresenius Kabi announced a voluntary recall of one lot of dexmedetomidine HCL in 0.9% sodium chloride injection due to a trace amount of lidocaine present in the lot. 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-single-lot-dexmedetomidine-hydrochloride-injection Source: FDA website

The Food and Drug Administration (FDA) approved Dificid® (fidaxomicin tablets) for use in pediatric individuals 6 months of age and older for the treatment of Clostridioides difficile (C. difficile) associated diarrhea (CDAD). The approval includes a new oral suspension formulation. Source: FDA website

The Food and Drug Administration (FDA) is warning that taking higher than recommended doses of over-the-counter (OTC) allergy medicine diphenhydramine can lead to serious heart problems, seizures, coma, or death. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/benadryl-diphenhydramine-drug-safety-communication-serious-problems-high-doses-allergy-medicine Source: FDA website

The Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine tablets) for the treatment of human immunodeficiency virus 1 (HIV-1) infection in individuals who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. Source: FDA website

The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) pre-filled pen formulation for all indications in individuals aged 12 years and older, which includes use in certain individuals with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration. Source: FDA website

The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of spasticity in pediatric individuals 2 years of age and older, including those with upper and lower limb spasticity caused by cerebral palsy. Source: FDA website

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

The Food and Drug Administration (FDA) approved Elyxyb (celecoxib oral solution) for acute treatment of migraine with or without aura in adults. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds with any of the six HCV genotypes without cirrhosis or with mild cirrhosis. Epclusa in combination with ribavirin is indicated for the treatment of children 6 years and older or weighing at least 37 pounds with severe cirrhosis. Source: FDA website

The Food and Drug Administration (FDA) approved Epidiolex® (cannabidiol oral solution) for the treatment of seizures associated with tuberous sclerosis complex (TSC) in individuals one year of age and older. Source: FDA website

The Food and Drug Administration (FDA) is alerting consumers and healthcare providers that EpiPen® (epinephrine 0.3 mg) and EpiPen Jr® (epinephrine 0.15 mg) auto-injectors, and authorized generic versions, may have delayed injection or be prevented from properly injecting. 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-epipen-auto-injector-errors-related-device Source: FDA website

The Food and Drug Administration (FDA) approved ErelziTM (etanercept-szzs injection) for the treatment of individuals ages 4 to 17 years with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website

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

The Food and Drug Administration (FDA) approved EvrysdiTM (risdiplam oral solution) for the treatment of spinal muscular atrophy (SMA) in individuals 2 months of age and older. Source: FDA website

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

The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). Source: FDA website

The Food and Drug Administration (FDA) approved Fensolvi® (leuprolide acetate sustained release subcutaneous injection) for the treatment of pediatric individuals 2 years of age and older with central precocious puberty. Source: FDA website

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

The Food and Drug Administration (FDA) approved Fetroja® (cefiderocol injection) for the treatment of adults with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative microorganisms. Source: FDA website

The Food and Drug Administration (FDA) approved Fintepla® (fenfluramine oral solution) for the treatment of Dravet syndrome in individuals 2 years of age and older. Source: FDA website

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

Fusion Health and Vitality announced a voluntary recall of all lots of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 due to unapproved use of a food additive. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-health-and-vitality-issues-voluntary-nationwide-recall-core-essential-nutrients-and-immune Source: FDA website

The Food and Drug Administration (FDA) approved GavretoTM (pralsetinib capsules) for adult and pediatric individuals 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Source: FDA website

The Food and Drug Administration (FDA) approved Gemtesa® (vibegron tablets) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. Source: FDA website

The Food and Drug Administration (FDA) approved GimotiTM (metoclopramide nasal spray) for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Source: FDA website

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

Granules Pharmaceuticals announced a voluntary recall of twelve lots of metformin hydrochloride extended-release 750 mg tablets due to the detection of N-Nitrosodimethylamine (NDMA) levels 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/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website

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

The Food and Drug Administration (FDA) approved Iclusig® (ponatinib tablets) for adults with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. Source: FDA website

The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib tablets and capsules) to include combination use with rituximab for the initial treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Source: FDA website

The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) as a first-line treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide). Source: FDA website

The Food and Drug Administration (FDA) approved InmazebTM (atoltivimab/maftivimab/odesivimab-ebgn injection) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric individuals, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Source: FDA website

The Food and Drug Administration (FDA) approved Inqovi® (decitabine/cedazuridine injection) for the treatment of adults with certain myelodysplastic syndromes (MDS). Source: FDA website

Based on Food and Drug Administration (FDA) review of new data from three clinical trials, the boxed warning about amputation risk from the diabetes medicine canagliflozin (Invokana® , Invokamet® , Invokamet® XR) was removed from the prescribing information. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/invokana-invokamet-invokamet-xr-canagliflozin-medwatch-safety-alert-boxed-warning-about-risk-leg-and Source: FDA website

There has been increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Food and Drug Administration (FDA) is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ivermectin-intended-animals-letter-stakeholders-do-not-use-humans-treatment-covid-19 Source: FDA website

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

The Food and Drug Administration (FDA) approved Jublia® (efinaconazole topical solution) for the treatment of onychomycosis in children six years and older. Source: FDA website

The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) to include additional responsive mutations in people with cystic fibrosis ages 4 months and older. Source: FDA website

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

Hikma Pharmaceuticals announced an expansion of a previous voluntary recall of certain lots of ketorolac tromethamine injection due to the presence of particulate matters. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-ketorolac-tromethamine-injection Source: FDA website

The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Source: FDA website

The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Source: FDA website

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

The Food and Drug Administration (FDA) approved Kineret® (anakinra injection) for treatment of deficiency of interleukin-1 receptor antagonist. Source: FDA website

The Food and Drug Administration (FDA) approved Klisyri® (tirbanibulin topical ointment) for the treatment of actinic keratosis of the face or scalp. Source: FDA website

The Food and Drug Administration (FDA) approved KoselugoTM (selumetinib capsules) for the treatment of children 2 years of age and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs). Source: FDA website

The Food and Drug Administration (FDA) approved KynmobiTM (apomorphine sublingual film) for the acute, intermittent treatment of OFF episodes in individuals with Parkinson’s disease. Source: FDA website

ICU Medical announced a voluntary recall of one lot of Lactated Ringer’s injection due to the presence of particulate matter identified as iron oxide. 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-lactated-ringers-injection-usp-due-presence Source: FDA website

Taro Pharmaceuticals announced a voluntary recall of one lot of lamotrigine 100 mg tablets due to cross contamination with a small amount of another drug substance (enalapril maleate) used to manufacture another product at the same facility. 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-inc-issues-voluntary-nationwide-recall-lamotrigine-tablets-usp-100-mg-100 Source: FDA website

The Food and Drug Administration (FDA) approved Levothyroxine sodium 100 mcg/mL intravenous solution for the treatment of myxedema coma. Source: FDA website

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

Lohxa LLC announced a voluntary recall of specific lots of chlorhexidine gluconate oral rinse 0.12% 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-chlorhexidine-gluconate-oral-rinse-usp-012-due Source: FDA website

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

Lupin Pharmaceuticals announced a voluntary recall of one lot of metformin hydrochloride extended-release 500 mg tablets after a Food and Drug Administration (FDA) analysis found the product to contain N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your health care 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-one-lot-metformin-hydrochloride Source: FDA website

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

The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for first-line maintenance treatment with bevacizumab for homologous recombination deficiency (HRD)-positive advanced ovarian cancer. Source: FDA website

The Food and Drug Administration (FDA) approved LyumjevTM (insulin lispro-aabc rapid-acting injection) to improve glycemic control in adults with type 1 and type 2 diabetes. Source: FDA website

The Food and Drug Administration (FDA) approved MargenzaTM (margetuximab-cmkb injection) in combination with chemotherapy, for the treatment of adults with metastatic human epidermal growth factor receptor 2 (HER2)- positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Source: FDA website

Marksans Pharma announced an expanded voluntary recall to include an additional 76 lots of unexpired lots of metformin hydrochloride extended-release 500 and 750 mg tablets due to levels of N-Nitrosodimethylamine (NDMA) exceeding the acceptable daily limit in some lots. Contact your healthcare provider with questions. More detail may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride Source: FDA website

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

The Food and Drug Administration (FDA) is alerting consumers and health care providers to several voluntary recalls of extended release metformin by certain companies. The companies are recalling metformin due to the possibility they could contain nitrosodimethylamine (NDMA) above the acceptable intake limit. Contact your healthcare provider with questions. More details and a list of companies may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_campaign=Several%20Companies%20Voluntarily%20Recall%20Extended%20Release%20Metformin&utm_medium=email&utm_source=Eloqua Source: FDA website

Nostrum Laboratories announced a voluntary recall of two lots of metformin extended-release tablets 750 mg due to N-Nitrosodimethylamine (NDMA) content above the acceptable daily intake (ADI) 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-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets Source: FDA website

The Food and Drug Administration (FDA) approved MilprosaTM (progesterone vaginal system) to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology treatment program for infertile women up to and including 34 years of age. Source: FDA website

Aurobindo announced a voluntary recall of one lot of mirtazapine tablets due to a label error on declared strength. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-issues-voluntary-nationwide-recall-mirtazapine-tablets-lot-number Source: FDA website

The Food and Drug Administration (FDA) approved Monoferric™ (ferric derisomaltose injection) for the treatment of iron deficiency anemia in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease. Source: FDA website

The Food and Drug Administration (FDA) approved Mycapssa® (octreotide capsules) for the long-term maintenance treatment of individuals with acromegaly who have responded to and tolerated octreotide or lanreotide. Source: FDA website

Mylan announced a voluntary recall of four lots of amiodarone injection and tranexamic acid injection due to carton 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/mylan-initiates-voluntary-nationwide-recall-four-lots-amiodarone-hcl-injection-usp-and-tranexamic Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Nexletol™ (bempedoic acid tablets) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Source: FDA website

The Food and Drug Administration (FDA) approved Nextstellis® (drospirenone/estetrol tablets) for use by females of reproductive potential to prevent pregnancy. Source: FDA website

Mylan announced a voluntary recall of 3 lots of nizatidine capsules due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace Source: FDA website

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

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

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

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

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

The Food and Drug Administration (FDA) approved Nurtec® (rimegepant orally disintegrating tablets) for the acute treatment of migraine in adults. Source: FDA website

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

The Food and Drug Administration (FDA) approved Ofev® (nintedanib capsules) to treat individuals with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. Source: FDA website

The Food and Drug Administration (FDA) approved Ongentys® (opicapone capsules) as add-on treatment for individuals with Parkinson's disease experiencing "off" episodes. Source: FDA website

The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) as first-line treatment for individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) (≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Source: FDA website

The Food and Drug Administration (FDA) is requiring drug manufacturers for all opioid pain relievers and drugs to treat opioid use disorder to add new recommendations about naloxone to the prescribing information. Contact your health care provider with questions More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/opioid-pain-relievers-or-medicines-treat-opioid-use-disorder-medwatch-safety-alert-fda-recommends Source: FDA website

The Food and Drug Administration (FDA) approved Oriahnn® (elagolix/estradiol/norethindrone acetate co-packaged capsules) for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Source: FDA website

The Food and Drug Administration (FDA) approved Ozempic® (semaglutide injection) for reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease (CVD). Source: FDA website

The Food and Drug Administration (FDA) approved Palforzia™ (peanut allergen oral powder) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Source: FDA website

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

The Food and Drug Administration (FDA) approved Pataday® Once Daily Relief (olopatadine hydrochloride ophthalmic 0.2% solution and drops) for over-the-counter (OTC) use for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander. Source: FDA website

The Food and Drug Administration (FDA) approved PemazyreTM (pemigatinib tablets) for treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement detected by FDA-approved test. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved PhesgoTM (pertuzumab/trastuzumab/hyaluronidase-zzxf subcutaneous injection) for use in combination with chemotherapy as neoadjuvant treatment of individuals with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer or as adjuvant treatment of individuals with HER2-positive early breast cancer at high risk of recurrence. Also approved for use in combination with docetaxel for treatment of individuals with HER2- positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Source: FDA website

Dr. Reddy’s announced a voluntary recall of phytonadione injectable emulsion 10 mg/mL single-dose ampules due to breaking and shattering upon opening. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10 Source: FDA website

The Food and Drug Administration (FDA) approved Pizensy (lactitol powder for oral solution) for the treatment of chronic idiopathic constipation in adults. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Prezcobix® (cobicistat/darunavir tablets) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus 1 (HIV-1) infection in treatment naïve and treatment-experienced pediatric individuals weighing at least 40 kg with no darunavir resistance-associated substitutions. Source: FDA website

The Food and Drug Administration (FDA) approved QdoloTM (tramadol oral solution) for adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website

The Food and Drug Administration (FDA) approved QinlockTM (ripretinib tablets) the treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Reblozyl® (luspatercept-aamt injection) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adults with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Source: FDA website

The Food and Drug Administration (FDA) is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/remdesivir-gilead-sciences-fda-warns-newly-discovered-potential-drug-interaction-may-reduce Source: FDA website

Efficient Laboratories announced a voluntary recall of three lots of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. These products are used to treat symptoms of the flu and the common cold. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/efficient-laboratories-inc-issues-voluntary-nationwide-recall-rompe-pecho-ex-rompe-pecho-cf-and Source: FDA website

The Food and Drug Administration (FDA) approved Rubraca® (rucaparib tablets) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Source: FDA website

The Food and Drug Administration (FDA) approved Ryplazim® (plasminogen injection) for the treatment of individuals with plasminogen deficiency type 1. Source: FDA website

The Food and Drug Administration (FDA) approved Sarclisa® (isatuximab injection) for the treatment of adults with multiple myeloma, in combination with pomalidomide and dexamethasone, who have received at least two prior therapies. Source: FDA website

The Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to individuals who, in a health care setting, are self-collecting nasal samples for SARS-CoV-2 testing. Contact your healthcare provider with questions. More detail may be viewed at: https://www.fda.gov/medical-devices/letters-health-care-providers/recommendations-providing-clear-instructions-patients-who-self-collect-anterior-nares-nasal-sample Source: FDA website

The Food and Drug Administration (FDA) approved SemgleeTM (insulin glargine injection) to control high blood sugar in adults with type 2 diabetes and adult and pediatric individuals with type 1 diabetes. Source: FDA website

The Food and Drug Administration (FDA) approved SesquientTM (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric individuals. Source: FDA website

The Food and Drug Administration (FDA) approved Simponi Aria® (golimumab injection) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA). Source: FDA website

The Food and Drug Administration (FDA) approved Sirturo® (bedaquiline 20 mg tablets) for the treatment of pulmonary multi-drug resistant tuberculosis as part of combination therapy in individuals 5 to 12 years of age and weighing at least 15 kg. Source: FDA website

The Food and Drug Administration (FDA) approved Sklice® (ivermectin topical lotion) for over-the-counter (OTC) treatment of head lice infestation in individuals 6 months of age and older. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of pediatric individuals 6 to 11 years of age with moderate to severe plaque psoriasis. Source: FDA website

The Food and Drug Administration (FDA) approved Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate oral solution) for cleansing of the colon in preparation for colonoscopy in pediatric individuals 12 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Symdeko® (tezacaftor/ivacaftor and ivacaftor) to include additional responsive mutations in people with cystic fibrosis ages 6 years and older. Source: FDA website

The Food and Drug Administration (FDA) approved TabrectaTM (capmatinib tablets) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Source: FDA website

The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of pediatric individuals 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website

The Food and Drug Administration (FDA) approved TecartusTM (brexucabtagene autoleucel intravenous infusion) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Source: FDA website

The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website

The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with Cotellic® (cobimetinib tablets) and Zelboraf® (vemurafenib tablets) for the treatment of BRAF V600 mutation-positive advanced melanoma. Source: FDA website

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

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

Teva announced a voluntary recall of fourteen lots of metformin hydrochloride extended-release 500 and 750 mg tablets due to the detection of N-Nitrosodimethylamine (NDMA) concentrations in excess of established levels. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-initiates-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website

The Food and Drug Administration (FDA) approved Tivicay® (dolutegravir tablets) to treat human immunodeficiency virus 1 (HIV)-1 infection in pediatric individuals at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments. Source: FDA website

The Food and Drug Administration (FDA) approved Totect® (dexrazoxane injection) for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and who will continue to receive doxorubicin therapy to maintain tumor control. Source: FDA website

The Food and Drug Administration (FDA) approved TralementTM (trace elements injection) in adult and pediatric individuals weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Source: FDA website

The Food and Drug Administration (FDA) approved Tremfya® (guselkumab injection) for the treatment of adults with active psoriatic arthritis. Source: FDA website

The Food and Drug Administration (FDA) approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. Source: FDA website

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

The Food and Drug Administration (FDA) approved Trulicity® (dulaglutide injection) for the reduction of cardiovascular (CV) risks in individuals with type 2 diabetes. Source: FDA website

The Food and Drug Administration (FDA) approved TukysaTM (tucatinib tablets) for second-line or greater treatment of adults with advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, including individuals with brain metastases, in combination with trastuzumab and capecitabine. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Ultravate® (halobetasol propionate lotion) for the treatment of plaque psoriasis in pediatric individuals 12 years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved UpliznaTM (inebilizumab-cdon injection) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody (individuals who are anti-aquaporin-4 or AQP4 antibody positive). Source: FDA website

The Food and Drug Administration (FDA) approved Valtoco® (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in individuals with epilepsy 6 years of age and older. Source: FDA website

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

The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablet, oral solution, and injection) as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in individuals four years of age and older. The injection is now also approved for the treatment of partial-onset seizures in individuals four years of age and older. Source: FDA website

The Food and Drug Administration (FDA) approved Voltaren Arthritis Pain (diclofenac topical 1% gel) for over-the-counter (OTC) use for the temporary relief of arthritis pain. Source: FDA website

The Food and Drug Administration (FDA) approved Vyepti™ (eptinezumab injection) for the preventive treatment of migraine in adults. Source: FDA website

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

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

The Food and Drug Administration (FDA) approved Winlevi® (clascoterone cream) for the treatment of acne vulgaris in individuals 12 years and older. Source: FDA website

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

The Food and Drug Administration (FDA) approved XeglyzeTM (abametapir topical lotion) for the treatment of head lice infestation in individuals 6 months of age and older. Source: FDA website

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

The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of individuals aged 2 years and older with chronic sialorrhea, or drooling. Source: FDA website

The Food and Drug Administration (FDA) approved XofluzaTM (baloxavir marboxil tablets and oral granules) for post-exposure prevention of influenza in individuals 12 years of age and older after contact with an individual who has the flu. A new oral granule for mixing in water was also approved. Source: FDA website

The Food and Drug Administration (FDA) approved Xolair® (omalizumab subcutaneous injection) as add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids. Source: FDA website

The Food and Drug Administration (FDA) approved Xpovio® (selinexor tablets) in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy. Source: FDA website

The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide tablets) for the treatment of individuals with castration-resistant prostate cancer or metastatic castration-sensitive prostate cancer. Source: FDA website

The Food and Drug Administration (FDA) approved XywavTM (calcium/magnesium/potassium/sodium oxybates oral solution) for cataplexy or excessive daytime sleepiness associated with narcolepsy. Xywav contains 92% less sodium per dose than currently available sodium oxybate formulation. Source: FDA website

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

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

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

The Food and Drug Administration (FDA) approved ZilxiTM (minocycline topical foam) for the treatment of inflammatory lesions of rosacea in adults. Source: FDA website

The Food and Drug Administration (FDA) approved ZokinvyTM (lonafarnib capsule) to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in individuals one year of age and older. Source: FDA website

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

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

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

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

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