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
ABH Nature's Products, ABH Pharma, and Stocknutra.com
Drug Recall 01-23-20
Tazverik
New Drug 01-23-20
Abecma
New Drug 03-26-21
Acella Pharmaceuticals
Drug Recall 09-18-20
Actemra
New Indication 03-04-21
Acyclovir
Drug Recall 03-25-21
Aduhelm
New Drug 06-07-21
Ajovy Autoinjector
New Formulation 01-28-20
Akynzeo
New Formulation 06-02-20
Albuterol
Drug Recall 09-21-20
Alkindi Sprinkle
New Formulation 09-29-20
Alunbrig
New Indication 05-22-20
American Health Packaging
Drug Recall 02-27-20
Amneal
Drug Recall 06-02-20
Amondys 45
New Drug 02-25-21
Anagrelide
Drug Recall 12-09-20
Anjeso
New Formulation 02-20-20
Apotex
Drug Recall 05-28-20
Appco Pharma
Drug Recall 01-08-20
Arcalyst
New Indication 12-18-20
Arcalyst
New Indication 03-18-21
ArmonAir Digihaler
New Formulation 02-24-20
Artesunate
New Formulation 05-26-20
Audenz
New Formulation 02-03-20
AvKARE
Drug Recall 12-09-20
AXIA Pharmaceutical
Drug Recall 01-17-20
Azstarys
New Drug 03-02-21
Barhemsys
New Drug 02-27-20
Bavencio
New Indication 06-30-20
Bayshore Pharmaceuticals
Drug Recall 08-20-20
Belviq; Belviq XR
Drug Withdrawal 02-14-20
Benlysta
New Indication 12-16-20
Benzedrex
Drug Warning 03-25-21
Benzodiazepines
Drug Warning 09-23-20
Blenrep
New Drug 08-05-20
Botox
New Indication 02-09-21
Botox
Expanded Indication 07-08-20
Braftovi
New Indication 04-08-20
Brexafemme
New Drug 06-01-21
Breyanzi
New Drug 02-05-21
Breztri Aerosphere
New Formulation 07-23-20
Brilinta
New Indication 05-28-20
Brilinta
New Indication 11-05-20
Bronchitol
New Formulation 10-30-20
Byfavo
New Drug 07-02-20
Bynfezia Pen
New Formulation 01-28-20
Cabenuva
New Drug 01-21-21
Camcevi
New Formulation 05-25-21
Cannabidiol
Drug Warning 04-23-20
Carbaglu
New Indication 01-22-21
Ceftazidime and dextrose
Drug Recall 04-20-20
ChloraPrep
Drug Recall 03-22-21
Cisatracurium besylate
Drug Recall 01-28-21
Clopidogrel
Drug Recall 04-17-20
Clozapine
Drug Warning 01-28-20
Cosela
New Drug 02-12-21
Cosentyx
New Indication 06-16-20
Cosentyx
Expanded Indication 05-28-21
Crysvita
New Indication 06-18-20
Curative SARS-CoV-2 Test
Drug Warning 01-07-21
Cymbalta
Expanded Indication 04-20-20
Cyramza
New Indication 05-29-20
Cystadrops
New Formulation 08-19-20
Danyelza
New Drug 11-25-20
Daptomycin
Drug Recall 07-07-20
Darzalex
Expanded Indication 08-20-20
Darzalex Faspro
New Indication 01-11-21
Darzalex Faspro
New Indication 01-15-21
Darzalex Faspro
New Formulation 05-01-20
DDAVP, Desmopressin Acetate, and Stimate
Drug Recall 08-06-20
Dental Amalgam
Drug Warning 09-24-20
Denton Pharma
Drug Recall 01-08-20
Dexmedetomidine hydrochloride
Drug Recall 11-20-20
Dexmedetomidine hydrochloride
Drug Recall 07-23-20
Dificid
Expanded Indication 01-27-20
Diovan
New Indication 04-19-21
Diphenhydramine
Drug Warning 09-24-20
Dojolvi
New Drug 06-30-20
Dovato
Expanded Indication 08-06-20
Dupixent
Expanded Indication 05-26-20
Dupixent
New Formulation 06-19-20
Durysta
New Formulation 03-05-20
Dysport
Expanded Indication 07-08-20
Ebanga
New Drug 12-21-20
Edurant
Expanded Indication 01-21-21
Elyxyb
New Formulation 05-05-20
Empaveli
New Drug 05-14-21
Enhertu
New Indication 01-15-21
Enoxaparin sodium
Drug Recall 02-03-21
Enspryng
New Drug 08-14-20
Entresto
New Indication 02-16-21
Epclusa
Expanded Indication 03-19-20
Epclusa
Expanded Indication 04-15-20
Epidiolex
New Indication 07-31-20
Epinephrine auto-injectors
Drug Warning 06-01-20
EpiPen; EpiPen Jr
Drug Warning 03-24-20
Eraxis
Expanded Indication 09-22-20
Erelzi
Expanded Indication 06-11-20
Esomeprazole orally disintegrating tablet
New Formulation 10-20-20
Eucrisa
Expanded Indication 03-24-20
Evekeo ODT
New Indication 04-16-21
Evkeeza
New Drug 02-11-21
Evotaz
Expanded Indication 07-31-20
Evrysdi
New Drug 08-07-20
Exparel
Expanded Indication 03-22-21
Eysuvis
New Formulation 10-27-20
Fabrazyme
New Indication 03-11-21
Farxiga
New Indication 05-05-20
Farxiga
New Indication 04-30-21
Fecal microbiota for transplantation
Drug Warning 04-11-20
Fensolvi
New Formulation 05-01-20
Ferriprox
New Formulation 05-22-20
Ferriprox
New Indication 04-30-21
Fetroja
New Indication 09-25-20
Finasteride Plus
Drug Recall 05-12-20
Fintepla
New Formulation 06-26-20
Fluad Quadrivalent
Expanded Indication 02-24-20
Flucelvax Quadrivalent
New Indication 03-05-21
Fotivda
New Drug 03-10-21
Fusion Health and Vitality
Drug Recall 11-23-20
FUSION IV Pharmaceuticals
Drug Recall 01-21-20
Gardasil 9
New Indication 06-12-20
Gavreto
New Indication 12-01-20
Gavreto
New Drug 09-04-20
Gemtesa
New Drug 12-23-20
Gericare Eye Wash
Drug Recall 04-15-20
Gimoti
New Formulation 06-19-20
Gocovri
New Indication 02-01-21
Granules Pharmaceuticals
Drug Recall 07-06-20
Guanfacine
Drug Recall 03-31-21
Haegarda
Expanded Indication 09-28-20
Hetlioz and Hetlioz LQ
New Indication and New Formulation 12-01-20
Humira
New Indication 02-24-21
Hydroxychloroquine and chloroquine
Drug Warning 04-24-20
Iclusig
New Indication 12-18-20
Ilaris
New Indication 06-16-20
Imbruvica
Expanded Indication 04-21-20
Imcivree
New Drug 11-25-20
Imfinzi
New Indication 03-27-20
Impeklo
New Formulation 05-19-20
Inmazeb
New Drug 10-14-20
Inqovi
New Drug 07-07-20
Invokamet, Invokamet XR
Expanded Indication 01-27-20
Invokana, Invokamet, Invokamet XR
Drug Warning 08-26-20
Isturisa
New Drug 03-06-20
Ivermectin
Drug Warning 04-11-20
Jelmyto
New Formulation 04-15-20
Jemperli
New Drug 04-22-21
Jublia
Expanded Indication 04-26-20
Kalydeco
Expanded Indication 09-24-20
Kalydeco
Expanded Indication 12-21-20
Kesimpta
New Drug 08-20-20
Ketorolac tromethamine
Drug Recall 01-10-21
Ketorolac tromethamine
Drug Recall 04-20-20
Ketorolac tromethamine
Drug Recall 03-05-20
Keytruda
New Indication 03-22-21
Keytruda
New Indication 06-16-20
Keytruda
New Indication 06-24-20
Keytruda
Expanded Indication 10-14-20
Keytruda
New Indication 01-08-20
Keytruda
New Indication 11-13-20
Keytruda
New Indication 06-29-20
Keytruda
New Indication 05-05-21
Kimyrsa
New Drug 03-15-21
Kineret
New Indication 12-18-20
Klisyri
New Drug 12-14-20
Kloxxado
New Formulation 04-29-21
Koselugo
New Drug 04-10-20
Kynmobi
New Formulation 05-22-20
Labetalol hydrochloride in dextrose
New Formulation 11-09-20
Lactated Ringer's
Drug Recall 05-08-20
Lamictal
Drug Warning 03-21-21
Lamotrigine
Drug Recall 01-10-20
Lampit
New Drug 08-06-20
Levothyroxine sodium
New Formulation 05-17-21
Lialda
Expanded Indication 06-26-20
Libtayo
New Indication 02-09-21
Libtayo
New Indication 02-22-21
Limbrel
Drug Recall 04-15-20
Lohxa
Drug Recall 11-09-20
Lorbrena
New Indication 03-03-21
Lorcaserin
Drug Warning 01-14-20
Lumakras
New Drug 05-28-21
Lupin Pharmaceuticals
Drug Recall 07-08-20
Lupin Pharmaceuticals
Drug Recall 06-11-20
Lupkynis
New Drug 01-22-21
Lybalvi
New Drug 05-28-21
Lynparza
New Indication 05-19-20
Lynparza
Expanded Indication 05-08-20
Lyumjev
New Formulation 06-15-20
Margenza
New Drug 12-16-20
Marksans Pharma
Drug Recall 06-05-20
Marksans Pharma
Drug Recall 10-05-20
Medical Action Industries
Drug Recall 05-24-21
MenQuadfi
New Formulation 04-24-20
Metformin Extended-Release
Drug Recall 07-13-20
Metformin extended-release tablets 500 mg
Drug Recall 11-04-20
Metformin extended-release tablets 750 mg
Drug Recall 11-04-20
Metformin Hydrochloride Extended-Release
Drug Recall 05-29-20
Milprosa
New Formulation 04-29-20
MiniMed 600 Series insulin pumps
Drug Recall 02-12-20
Mirena
Expanded Indication 08-20-20
Mirtazapine
Drug Recall 01-02-20
Monjuvi
New Drug 07-31-20
Monoferric
New Formulation 01-16-20
Mycapssa
New Formulation 06-26-20
Myfembree
New Drug 05-26-21
Mylan
Drug Recall 08-28-20
Mylotarg
Expanded Indication 06-16-20
Myrbetriq
New Formulation 03-25-21
Myrbetriq
Expanded Indication 03-25-21
Natroba
New Indication 04-28-21
Nerlynx
Expanded Indication 02-26-20
Nexletol
New Drug 02-21-20
Nexlizet
New Formulation 02-26-20
Nextstellis
New Drug 04-15-21
Nizatidine
Drug Recall 04-15-20
Nizatidine
Drug Recall 01-08-20
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Drug Warning 10-15-20
Nostrum Laboratories
Drug Recall 01-26-21
Nostrum Laboratories
Drug Recall 01-06-21
Nostrum Laboratories
Drug Recall 01-05-21
Novo Nordisk Insulins
Drug Recall 05-10-21
NP Thyroid
Drug Recall 05-22-20
NP Thyroid
Drug Recall 05-01-21
Nplate
New Indication 01-28-21
Nucala
New Indication 09-25-20
Nulibry
New Drug 02-26-21
Nurtec
New Drug 02-27-20
Nurtec ODT
New Indication 05-27-21
Ocaliva
Drug Warning 05-26-21
Ofev
New Indication 03-09-20
Olinvyk
New Drug 08-07-20
Ongentys
New Drug 04-24-20
Onureg
New Formulation 09-01-20
Opdivo
Expanded Indication 05-15-20
Opdivo
New Indication 06-10-20
Opdivo
Expanded Indication 01-22-21
Opdivo
New Indication 05-20-21
Opdivo
New Indication 04-16-21
Opdivo and Yervoy
New Indication 10-02-20
Opdivo and Yervoy
New Indication 03-11-20
Opdivo and Yervoy
New Indication 05-26-20
Opioid pain relievers and drugs to treat opioid use disorder
Drug Warning 07-23-20
Orgovyx
New Drug 12-18-20
Oriahnn
New Formulation 05-29-20
Orladeyo
New Drug 12-03-20
Oxlumo
New Drug 11-23-20
Ozempic
Expanded Indication 01-16-20
Palforzia
New Drug 01-31-20
Panzyga
New Indication 02-11-21
Paroex
Drug Recall 01-05-21
Paroex
Drug Recall 10-28-20
Pataday Once Daily Relief
New OTC 02-17-20
Pataday Twice Daily Relief
New OTC 02-17-20
Pemazyre
New Drug 04-17-20
Pemfexy
New Formulation 02-14-20
Pepaxto
New Drug 02-26-21
Phenylephrine
Drug Recall 03-12-21
Phenytoin
Drug Recall 02-21-20
Phesgo
New Formulation 06-29-20
Phexxi
New Formulation 05-22-20
Phytonadione
Drug Recall 03-26-20
Pizensy
New Formulation 02-12-20
Pomalyst
New Indication 05-14-20
Ponvory
New Drug 03-18-21
Posimir
New Formulation 02-01-21
Praluent
New Indication 04-01-21
Prezcobix
Expanded Indication 07-31-20
Qdolo
New Formulation 09-01-20
Qelbree
New Drug 04-02-21
Qinlock
New Drug 05-15-20
Qutenza
New Indication 07-17-20
Qwo
New Formulation
Ragwitek
New Indication 04-19-21
Ranitidine
Drug Warning 04-01-20
Rapivab
Expanded Indication 01-28-21
Reblozyl
New Indication 04-03-20
Recarbrio
New Indication 06-04-20
Regenecare HA Hydrogel
Drug Recall 12-02-20
Remdesivir
Drug Warning 06-15-20
Retevmo
New Drug 05-08-20
Riomet ER
Drug Recall 09-23-20
RLC Labs
Drug Recall 09-06-20
Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid
Drug Recall 02-03-20
Roszet
New Formulation 03-23-21
Rubraca
New Indication 05-15-20
Rukobia
New Drug 07-02-20
Rybrevant
New Drug 05-21-21
Ryplazim
New Drug 06-04-21
Sabril
Expanded Indication 01-24-20
Sarclisa
New Indication 03-31-21
Sarclisa
New Drug 03-02-20
Saxenda
New Indication 12-04-20
Self-Collection of Nasal Samples
Drug Warning 10-13-20
Selzentry
New Indication 10-30-20
Semglee
New Formulation 06-11-20
Senna laxatives
Drug Recall 04-15-20
Sesquient
New Formulation 11-05-20
Sevenfact
New Drug 04-01-20
Simponi Aria
New Indication 09-29-20
Singulair
Drug Warning 03-04-20
Sirturo
New Formulation 05-27-20
Sivextro
Expanded Indication 06-19-20
Sklice
Rx to Over-the-Counter Switch 10-27-20
Sogroya
New Drug 08-28-20
Spironolactone
Drug Recall 03-10-21
Spravato
Expanded Indication 07-31-20
Spritam
Expanded Indication 01-19-21
Stelara
New Indication 07-29-20
Sunstar Americas
Drug Recall 12-29-20
Suprep
Expanded Indication 08-05-20
Sutab
New Formulation 10-10-20
Symdeko
Expanded Indication 12-21-20
Symtuza
Expanded Indication 03-05-20
Tabrecta
New Formulation 05-06-20
Tagrisso
New Indication 12-18-20
Taltz
New Indication 05-29-20
Taltz
Expanded Indication 03-27-20
Tazverik
New Indication 06-18-20
Tecartus
New Drug 07-24-20
Tecentriq
Drug Warning 09-08-20
Tecentriq
New Indication 05-18-20
Tecentriq
New Indication 07-30-20
Tecentriq
New Indication 05-29-20
Telmisartan
Drug Recall 03-25-21
Tembexa
New Drug 06-04-21
Tepezza
New Drug 01-21-20
Tepmetko
New Drug 02-03-21
Tetracycline
Drug Recall 04-17-20
Teva
Drug Recall 06-05-20
Thyquidity
New Formulation 11-30-20
Tivicay
Expanded Indication 06-12-20
Tivicay PD
New Formulation 06-12-20
Totect
New Indication 11-02-20
Tralement
New Formulation 07-02-20
Trelegy Ellipta
New Indication 09-09-20
Tremfya
New Indication 07-13-20
Triferic
New Formulation 03-27-20
Trijardy XR
New Formulation 01-27-20
Trikafta
Expanded Indication 12-21-20
Trodelvy
New Drug 04-22-20
Trodelvy
New Indication 04-13-21
True Metrix Air
Drug Recall 04-21-20
Trulicity
Expanded Indication 02-14-20
Truseltiq
New Drug 05-28-21
Tukysa
New Drug 04-17-20
Twirla
New Formulation 02-14-20
Tyvaso
New Indication 03-31-21
Ukoniq
New Drug 02-05-21
Ultomiris
Expanded Indication 06-07-21
Ultravate
Expanded Indication 08-27-20
Uplizna
New Drug 06-11-20
Upneeq
New Formulation 07-08-20
Valtoco
New Formulation 01-13-20
Veklury
New Drug 10-22-20
Verquvo
New Drug 01-20-21
VESIcare LS
New Formulation 05-26-20
Viltepso
New Drug 08-12-20
Vimpat
New Indication 11-16-20
Vocabria
New Drug 01-21-21
Voltaren Arthritis Pain
New OTC 02-17-20
Vyepti
New Drug 02-21-20
Vyxeos
Expanded Indication 03-30-21
Wakix
Expanded Indication 10-13-20
Wegovy
New Drug 06-04-21
Winlevi
New Drug 08-26-20
Wynzora
New Formulation 07-20-20
Xalkori
Expanded Indication 01-14-21
Xaracoll
New Formulation 08-28-20
Xeglyze
New Drug 07-24-20
Xeljanz
New Indication 09-25-20
Xeljanz and Xeljanz XR
Drug Warning 02-04-21
Xeomin
New Indication 08-19-20
Xeomin
New Indication 12-18-20
Xofluza
New Indication and New Formulation 11-23-20
Xolair
New Indication 11-30-20
Xpovio
New Indication 06-22-20
Xpovio
New Indication 12-18-20
Xtandi
New Formulation 08-04-20
Xyntha
New Indication 07-29-20
Xywav
New Formulation 07-21-20
Yervoy
Expanded Indication 05-25-21
Yescarta
New Indication 03-05-21
Zegalogue
New Drug 03-22-21
Zejula
Expanded Indication 04-29-20
Zeposia
New Drug 03-25-20
Zeposia
New Indication 05-27-21
Zepzelca
New Drug 06-15-20
Zilxi
New Formulation 05-28-20
Zipsor
Expanded Indication 05-25-21
Zokinvy
New Drug 11-20-20
Zosyn
Expanded Indication 05-26-20
Zynlonta
New Drug 04-23-21
Zynrelef
New Drug 05-12-21
Trikafta
Expanded Indication 06-08-21
Epclusa
Expanded Indication 06-10-21
Mavyret
Expanded Indication 06-10-21
Ayvakit
New Indication 06-16-21
Soaanz
New Formulation 06-14-21
Prevnar 20
New Formulation 06-08-21
Metformin
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-releasing intrauterine device) for the prevention of pregnancy for up to 7 years. Source: FDA website
Expanded Indication 08-11-21
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