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
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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
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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
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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
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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
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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
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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
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Drug Recall | 10-14-21 |
Flucelvax Quadrivalent
The Food and Drug Administration (FDA) approved Flucelvax® Quadrivalent (influenza vaccine injection) for active immunization in individuals 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website
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Expanded Indication | 10-15-21 |
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablet, oral solution, and injection) for monotherapy and adjunctive therapy
in the treatment of partial onset seizures in individuals 1 month and older to less than 4 years of age. Source: FDA website
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Expanded Indication | 10-14-21 |
Zimhi
The Food and Drug Administration (FDA) approved ZimhiTM (naloxone injection) for use in the treatment of opioid overdose. Source: FDA website
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New Formulation | 10-15-21 |
Seglentis
The Food and Drug Administration (FDA) approved Seglentis (celecoxib/tramadol tablets) for the treatment of acute pain in adults. Source: FDA website
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New Formulation | 10-18-21 |
Tyrvaya
The Food and Drug Administration (FDA) approved TyrvayaTM (varenicline nasal spray) for the treatment of the signs and symptoms of dry eye disease. Source: FDA website
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New Drug | 10-15-21 |
Methocarbamol
Bryant Ranch Prepack announced a voluntary recall of one lot of methocarbamol 500 mg due to mislabeling with the incorrect strength. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-methocarbamol-500mg-bottles-due-mislabeling Source: FDA website
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Drug Recall | 10-19-21 |
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for add-on maintenance treatment in moderate-to-severe asthma in children ages 6 to 11 years. Source: FDA website
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Expanded Indication | 10-20-21 |
Cutaquig
The Food and Drug Administration (FDA) approved Cutaquig® (human immune globulin subcutaneous injection) in pediatric individuals 2 years of age and older for the treatment of primary humoral immunodeficiency. Source: FDA website
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Expanded Indication | 10-22-21 |
Susvimo
The Food and Drug Administration (FDA) approved SusvimoTM (ranibizumab injection) for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Source: FDA website
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New Formulation | 10-22-21 |
Xipere
The Food and Drug Administration (FDA) approved XipereTM (triamcinolone acetonide injection for suprachoroidal use) for the treatment of macular edema associated with uveitis. Source: FDA website
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New Formulation | 10-22-21 |
Vuity
The Food and Drug Administration (FDA) approved VuityTM (pilocarpine 1.25% ophthalmic solution) for the treatment of presbyopia in adults. Source: FDA website
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New Formulation | 10-28-21 |
Purified Cortrophin Gel
The Food and Drug Administration (FDA) approved Purified Cortrophin® Gel (repository corticotropin injection) for the treatment of rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic disease, respiratory diseases, edematous states, and acute exacerbation of multiple sclerosis. Source: FDA website
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New Formulation | 11-01-21 |
Scemblix
The Food and Drug Administration (FDA) approved Scemblix® (asciminib tablets) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) and for the treatment of adults with Ph+ CML in CP with T315I mutation. Source: FDA website
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New Drug | 10-29-21 |
Monoject Flush Prefilled Saline Syringes
Aligned Medical Solutions announced a voluntary recall of Cardinal Health's MonojectTM Flush Prefilled Saline Syringes placed into kits due to the potential for the plunger to draw back after air has been expelled allowing for reintroduction of air back into the syringe. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-cardinal-healths Source: FDA website
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Drug Recall | 10-28-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of individuals with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Source: FDA website
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New Indication | 11-17-21 |
Dyanavel XR
The Food and Drug Administration (FDA) approved Dyanavel® XR (amphetamine extended-release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
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New Formulation | 11-04-21 |
Eprontia
The Food and Drug Administration (FDA) approved EprontiaTM (topiramate oral solution) as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in individuals 2 years of age or older: adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in individuals 2 years of age and older; and preventive treatment of migraine in individuals12 years of age and older. Source: FDA website
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New Formulation | 11-05-21 |
Dhivy
The Food and Drug Administration (FDA) approved DhivyTM (carbidopa/levodopa tablets) for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Source: FDA website
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New Formulation | 11-12-21 |
Besremi
The Food and Drug Administration (FDA) approved Besremi® (ropeginterferon alfa-2b-njft injection) for the treatment of adults with polycythemia vera (PV). Source: FDA source
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New Drug | 11-12-21 |
Voxzogo
The Food and Drug Administration (FDA) approved VoxzogoTM (vosoritide injection) to increase linear growth in pediatric individuals with achondroplasia who are 5 years of age and older with open epiphyses. Source: FDA website
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New Drug | 11-19-21 |
SterRx
SterRx announced a voluntary recall of approximately 240 lots of products due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-certain-sterrx-products Source: FDA website
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Drug Recall | 11-16-21 |
Injectafer
The Food and Drug Administration (FDA) approved Injectafer® (ferric carboxymaltose injection) for pediatric individuals 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron. Source: FDA website
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Expanded Indication | 11-19-21 |
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with carfilzomib plus dexamethasone for adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Source: FDA website
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Expanded Indication | 11-30-21 |
Lyvispah
The Food and Drug Administration (FDA) approved Lyvispah (baclofen oral granules) for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Lyvispah may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Source: FDA website
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New Formulation | 11-22-21 |
Livtencity
The Food and Drug Administration (FDA) approved Livtencity (maribavir tablets) for the treatment of adults and pediatric individuals (≥12 years of age and weighing ≥35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. Source: FDA website
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New Drug | 11-23-21 |
Fyarro
The Food and Drug Administration (FDA) approved Fyarro™ (sirolimus protein-bound particles for injectable suspension) for the treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), Source: FDA website
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New Drug | 11-22-21 |
PreHevbrio
The Food and Drug Administration (FDA) approved PreHevbrio™ (recombinant hepatitis B vaccine injection) for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. Source: FDA website
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New Vaccine | 12-01-21 |
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) approved in combination with chemotherapy for pediatric individuals (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Source: FDA website
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New Indication | 12-02-21 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of adult and pediatric (12 years and older) individuals with stage IIB or IIC melanoma following complete resection. Additionally, the Food and Drug Administration (FDA) expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric individuals (12 years and older). Source: FDA website
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New Indication | 12-03-21 |
Siklos
The Food and Drug Administration (FDA) approved Siklos® (hydroxyurea tablets) to include adults to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric individuals, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website
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New Indication | 12-07-21 |
Zynrelef
The Food and Drug Administration (FDA) approved Zynrelef® (bupivacaine/meloxicam extended-release solution for soft tissue or periarticular instillation) in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Source: FDA website
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Expanded Indication | 12-08-21 |
Xaciato
The Food and Drug Administration (FDA) approved XaciatoTM (clindamycin phosphate vaginal gel) for the treatment of bacterial vaginosis in females 12 years of age and older. Source: FDA website
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New Formulation | 12-07-21 |
Enoxaparin sodium
Sandoz announced a voluntary recall of one lot of enoxaparin sodium injection due to temperature excursion during shipment. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-one-lot-enoxaparin-sodium-injection-usp-40mg04-ml-due Source: FDA website
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Drug Recall | 12-03-21 |
Zepatier
The Food and Drug Administration (FDA) approved ZepatierTM (elbasvir/grazoprevir tablets) for the treatment of individuals aged 12 to less than 18 years with chronic hepatitis C (HCV) genotype 1 or 4 infection without cirrhosis. Source: FDA website
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Expanded Indication | 12-09-21 |
Oxbryta
The Food and Drug Administration (FDA) approved Oxbryta® (voxelotor tablets and tablets for oral suspension) to treat sickle cell disease in pediatric individuals aged four up to 11 years. Source: FDA website
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Expanded Indication/New Dosage Form | 12-17-21 |
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with active psoriatic arthritis who have had an inadequate response, or intolerance to, tumor necrosis factor (TNF) inhibitors. Source: FDA website
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New Indication | 12-14-21 |
Xeljanz/Xeljanz XR
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) and Xeljanz® XR (tofacitinib extended-release tablets) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website
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New Indication | 12-14-21 |
Orencia
The Food and Drug Administration (FDA) approved Orencia® (abatacept injection) for the prophylaxis of acute graft-versus-host disease (aGVHD) in combination with certain immunosuppressants. Source: FDA website
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New Indication | 12-15-21 |
Entadfi
The Food and Drug Administration (FDA) approved EntadfiTM (finasteride/tadalafil capsules) for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks. Source: FDA website
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New Formulation | 12-09-21 |
Tarpeyo
The Food and Drug Administration (FDA) approved TarpeyoTM (budesonide delayed-release capsules) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. Source: FDA website
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New Formulation | 12-15-21 |
Clozapine
The Food and Drug Administration (FDA) authorizes enforcement discretion to temporarily ease certain requirements of the clozapine risk evaluation and mitigation strategy (REMS) to help ensure continuity of care. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program?utm_medium=email&utm_source=govdelivery Source: FDA website
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Drug Warning | 12-16-21 |
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets and oral suspension) to treat venous thromboembolism (VTE) and to reduce the risk of VTE recurring in pediatric individuals from birth to younger than 18 years who have received at least five days of injectable or intravenous treatment for blood clots. It was also approved to prevent blood clots in pediatric individuals two years and older with congenital heart disease after the Fontan procedure, a type of open-heart surgery. Source: FDA website
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Expanded Indication/New Dosage Form | 12-20-21 |
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of adults with plaque psoriasis who are candidates for phototherapy or systemic therapy, regardless of severity level. Source: FDA website
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Expanded Indication | 12-20-21 |
Caplyta
The Food and Drug Administration (FDA) approved Caplyta® (lumateperone capsules) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Source: FDA website
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New Indication | 12-17-21 |
Vocabria
The Food and Drug Administration (FDA) approved Vocabria (cabotegravir sodium tablets) as oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension for human immunodeficiency (HIV)-1 pre-exposure prophylaxis (PrEP) and oral therapy for individuals who will miss planned injection dosing with cabotegravir injectable for HIV-1 PrEP.Source: FDA website
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New Indication | 12-20-21 |
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of active enthesitis-related arthritis (ERA) in individuals four years and older and active psoriatic arthritis (PsA) in individuals two years and older. Source: FDA website
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New Indication | 12-22-21 |
Dartisla ODT
The Food and Drug Administration (FDA) approved Dartisla ODT (glycopyrrolate orally disintegrating tablets) in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Source: FDA website
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New Formulation | 12-16-21 |
Apretude
The Food and Drug Administration (FDA) approved Apretude (cabotegravir extended-release injectable suspension) in at-risk adults and adolescents weighing at least 35 kg for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). Source: FDA website
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New Formulation | 12-20-21 |
Leqvio
The Food and Drug Administration (FDA) approved Leqvio® (inclisiran injection) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Source: FDA website
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New Drug | 12-22-21 |
Vyvgart
The Food and Drug Administration (FDA) approved VyvgartTM (efgartigimod alfa-fcab injection) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. Source: FDA website
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New Drug | 12-17-21 |
Tezspire
The Food and Drug Administration (FDA) approved TezspireTM (tezepelumab-ekko injection) as add-on maintenance treatment of adult and pediatric individuals aged 12 years and older with severe asthma. Source: FDA website
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New Drug | 12-17-21 |
Rexulti
The Food and Drug Administration (FDA) approved Rexulti® (brexpiprazole tablets) for the treatment of schizophrenia in individuals aged 13 to 17 years. Source: FDA website
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Expanded Indication | 12/27/2021 |
Tascenso ODT
The Food and Drug Administration (FDA) approved Tascenso ODTTM (fingolimod lauryl sulfate orally disintegrating tablets) for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in pediatric individuals 10 years of age and older and weighing less than or equal to 40 kg. Source: FDA website
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New Formulation | 12/23/2021 |
Adbry
The Food and Drug Administration (FDA) approved AdbryTM (tralokinumab-ldrm injection) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
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New Drug | 12/27/2021 |
Recorlev
The Food and Drug Administration (FDA) approved Recorlev® (levoketoconazole tablets) for the treatment of adults with Cushing’s syndrome with endogenous high cortisol levels for whom surgery is not an option or has not been curative. Source: FDA website
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New Drug | 12/30/2021 |
Metformin
Viona announced a voluntary recall of thirty three lots of metformin hydrochloride extended-release tablets 750 mg due to the detection of N-nitrosodimethylamine (NDMA) impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website
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Drug Recall | 12/29/2021 |
Clobetasol propionate ointment
Taro Pharmaceuticals announced a voluntary recall of one lot of clobetasol propionate ointment 0.05% packaged in 60 gram tubes due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-clobetasol-propionate-ointment-usp-005 Source: FDA website
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Drug Recall | 12/31/2021 |
Nitroglycerin lingual spray
Padagis announces a voluntary recall of nitroglycerin lingual spray due to a possible defective delivery system. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/padagis-issues-voluntary-nationwide-recall-nitroglycerin-lingual-spray-due-possible-defective Source: FDA website
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Drug Recall | 12/27/2021 |
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide fumarate tablets) to include treatment of human immunodeficiency virus (HIV)-1 infection in pediatric individuals at least 2 years of age and weighing at least 14 kg.Source: FDA website
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Expanded Indication | 01-07-22 |
Quviviq
The Food and Drug Administration (FDA) approved Quviviq (daridorexant tablets) for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.Source: FDA website
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New Drug | 01-07-22 |
Senna
Lohxa announced a voluntary recall of one lot of Senna Syrup 8.8 mg/5 mL unit-dose cups due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-senna-syrup-88mg5ml-due-microbial-contamination Source: FDA website
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Drug Recall | 01-13-22 |
Metformin
Viona Pharmaceuticals announced a voluntary recall of twenty-three lots of metformin hydrochloride extended-release tablets 750 mg due to detection of N-nitrosamine (NDMA) impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website
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Drug Recall | 01-12-22 |
Buprenorphine
The Food and Drug Administration (FDA) is warning that dental problems (tooth decay, cavities, oral infection, and loss of teeth) have been reported with medicines containing buprenorphine that are dissolved in the mouth for opioid use disorder and pain. The FDA is requiring a new warning be added to the prescribing information. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines Source: FDA website
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Drug Warning | 01-12-22 |
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib tablets) for the treatment of adults and children 12 years of age and older with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website
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New Indication | 01-14-22 |
Skyrizi
The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website
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New Indication | 01-24-22 |
Veklury
The Food and Drug Administration (FDA) approved Veklury® (remdesivir injection) for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Source: FDA website
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Expanded Indication | 01-21-22 |
Ryaltris
The Food and Drug Administration (FDA) approved RyaltrisTM (olopatadine hydrochloride/mometasone furoate nasal spray) for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric individuals 12 years of age and older. Source: FDA website
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New Formulation | 01-13-22 |
Cibinqo
The Food and Drug Administration (FDA) approved CibinqoTM (abrocitinib tablets) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website
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New Drug | 01-14-22 |
Semglee
Mylan Pharmaceuticals announced a voluntary recall of one batch of its non-interchangeable Semglee injection due to the potential for a missing label. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin Source: FDA website
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Drug Recall | 01-19-22 |
Solosec
The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules) for the treatment of bacterial vaginosis and trichomoniasis caused by Trichomonas vaginalis in individuals 12 years of age and older. Source: FDA website
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Expanded Indication | 01-26-22 |
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro® (doravirine tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website
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Expanded Indication | 01-27-22 |
Delstrigo
The Food and Drug Administration (FDA) approved DelstrigoTM (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website
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Expanded Indication | 01-27-22 |
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi® (recombinant von Willebrand factor injection) for routine prophylaxis to reduce the frequency of bleeding episodes in individuals with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy. Source: FDA website
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Expanded Indication | 01-31-22 |
Nucala
The Food and Drug Administration (FDA) approved Nucala (mepolizumab 40 mg prefilled syringe injection) as add-on maintenance treatment for children 6 to 11 years of age with severe asthma and with an eosinophilic phenotype. Source: FDA website
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New Formulation | 01-22-22 |
Kimmtrak
The Food and Drug Administration (FDA) approved Kimmtrak® (tebentafusp-tebn injection) for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). Source: FDA website
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New Drug | 01-26-22 |
Vabysmo
The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa injection for intravitreal use) for the treatment of adults with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Source: FDA website
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New Drug | 01-28-22 |
Polymyxin B
AuroMedics Pharma announced a voluntary recall of one lot of polymyxin B for injection due to a product complaint for the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial Source: FDA website
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Drug Recall | 01-28-22 |
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin hydrochloride extended-release tablets) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Source: FDA website
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New Indication | 02-03-22 |
Fleqsuvy
The Food and Drug Administration (FDA) approved FleqsuvyTM (baclofen oral suspension) for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Source: FDA website
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New Formulation | 02-04-22 |
Enjaymo
The Food and Drug Administration (FDA) approved EnjaymoTM (sutimlimab-jome injection) to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Source: FDA website
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New Drug | 02-04-22 |
Ukoniq
The Food and Drug Administration (FDA) is investigating a possible increased risk of death due to the cancer drug Ukoniq® (umbralisib tablets). The FDA is re-evaluating the risk versus benefit of Ukoniq and is continuing to look at results from the UNITY clinical trial. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-investigating-possible-increased-risk-death-lymphoma Source: FDA website
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Drug Warning | 02-03-22 |
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) to treat adults with heart failure regardless of left ventricular ejection fraction. Source: FDA website
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Expanded Indication | 02-24-22 |
Norliqva
The Food and Drug Administration (FDA) approved Norliqva® (amlodipine oral solution) for the treatment of hypertension in adults and children 6 years and older and for the treatment of coronary artery disease and angiographically documented coronary artery disease in individuals without heart failure or an ejection fraction <40%. Source: FDA website
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New Formulation | 02-24-22 |
Aspruzyo Sprinkle
The Food and Drug Administration (FDA) approved Aspruzyo SprinkleTM (ranolazine extended-release oral granules) for the treatment of chronic angina. Source: FDA website
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New Formulation | 02-28-22 |
Pyrukynd
The Food and Drug Administration (FDA) approved Pyrukynd® (mitapivat tablets) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Source: FDA website
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New Drug | 02-17-22 |
Carvykti
The Food and Drug Administration (FDA) approved CarvyktiTM (ciltacabtagene autoleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Source: FDA website
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New Drug | 02-28-22 |
Vonjo
The Food and Drug Administration (FDA) approved VonjoTM (pacritinib capsules) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Source: FDA website
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New Drug | 02-28-22 |
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with platinum-doublet chemotherapy for adults with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. Source: FDA website
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Expanded Indication | 03-04-22 |
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Source: FDA website
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Expanded Indication | 03-11-22 |
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as a single agent for individuals with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by a Food and Drug Administration (FDA)-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. Source: FDA website
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Expanded Indication | 03-21-22 |
Smoflipid
The Food and Drug Administration (FDA) approved Smoflipid® (lipid injectable emulsion) as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated expanded to include pediatric individuals. Source: FDA website
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Expanded Indication | 03-22-22 |
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website
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New Indication | 03-16-22 |
Adlarity
The Food and Drug Administration (FDA) approved Adlarity® (donepezil transdermal system) for the treatment of adults with mild, moderate, and severe dementia of the Alzheimer type. Source: FDA website
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New Formulation | 03-11-22 |
Xelstrym
The Food and Drug Administration (FDA) approved XelstrymTM (dextroamphetamine transdermal system) for the treatment of attention-deficit/hyperactivity disorder (ADHD) for adults and pediatric individuals 6 years and older. Source: FDA website
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New Formulation | 03-23-22 |
Hyftor
The Food and Drug Administration (FDA) approved HyftorTM (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric individuals 6 years of age and older. Source: FDA website
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New Formulation | 03-22-22 |
Ztalmy
The Food and Drug Administration (FDA) approved Ztalmy® (ganaxolone oral suspension) for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in individuals 2 years of age or older. Source: FDA website
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New Drug | 03-18-22 |
Opdualag
The Food and Drug Administration (FDA) approved OpdualagTM (nivolumab/relatlimab-rmbw injection) for the treatment of adult and pediatric individuals 12 years of age or older with unresectable or metastatic melanoma. Source: FDA website
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New Drug | 03-18-2022 |
Pluvicto
The Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan injection) for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Source: FDA website
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New Drug | 03-23-22 |
Sodium acetate
Fresenius Kabi announced a voluntary recall of seven lots of sodium acetate injection due to the presence of particulate matter.Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-recall-sodium-acetate-injection-usp-due-presence-particulate-matter Source: FDA website
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Drug Recall | 03-08-22 |
Quinapril/hydrochlorothiazide
Pfizer announced a voluntary recall of six lots of AccureticTM (quinapril HCL/hydrochlorothiazide) tablets distributed by Pfizer as well as five lots of two authorized generics distributed by Greenstone due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and Source: FDA website
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Drug Recall | 03-22-22 |
Orphenadrine citrate
Sandoz announced a voluntary recall of 13 lots of oral orphenadrine citrate 100 mg extended-release tablets due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due Source: FDA website
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Drug Recall | 03-23-22 |
Symjepi
Adamis Pharmaceuticals announced a voluntary recall of certain lots of SymjepiTM (epinephrine injection) due to the potential clogging of the needle preventing the dispensing of epinephrine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection Source: FDA website
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Drug Recall | 03-22-22 |
Fintepla
The Food and Drug Administration (FDA) approved Fintepla® (fenfluramine oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome in individuals two years of age and older. Source: FDA website
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New Indication | 03-25-22 |
Cabenuva
The Food and Drug Administration (FDA) approved Cabenuva (cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension) for expanded use of every 2-month dosing regimen to include the treatment of human immunodeficiency virus (HIV)-1 infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website
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Expanded Indication | 03-29-22 |
Vocabria and Edurant
The Food and Drug Administration (FDA) approved Vocabria (cabotegravir tablets) for expanded use in combination with Edurant® (rilpivirine tablets) as an oral, short-term treatment regimen followed by Cabenuva injection dosing regimen for the treatment of human immunodeficiency virus (HIV)-1 virus infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website
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Expanded Indication | 03-29-22 |
Tlando
The Food and Drug Administration (FDA) approved TlandoTM (testosterone undecanoate oral capsule) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
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New Formulation | 03-28-22 |
Triumeq PD
The Food and Drug Administration (FDA) approved Triumeq PD (abacavir/dolutegravir/lamivudine dispersible tablets for oral suspension) for the treatment of pediatric individuals weighing 10 kg to < 25 kg with human immunodeficiency virus type 1 (HIV-1). The original tablet formulation of Triumeq was also expanded to individuals weighing at least 10 kg. Source: FDA website
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New Formulation | 03-30-22 |
Idarubicin
Teva Pharmaceuticals announced a voluntary recall of one lot of idarubicin hydrochloride injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due Source: FDA website
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Drug Recall | 03-30-22 |
North American Custom Laboratories
The Food and Drug Administration (FDA) issued a warning not to use products intended to be sterile produced by North American Custom Laboratories due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom?utm_medium=email&utm_source=govdelivery Source: FDA website
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Drug Warning | 03-31-22 |
Iodine-containing contrast media
The Food and Drug Administration (FDA) approved a new warning to the prescribing label for the entire class of iodinated contrast media injections and monitoring recommendations for children 3 years or younger. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/iodine-containing-contrast-media-drug-safety-communication-fda-recommends-thyroid-monitoring-babies Source: FDA website
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Drug Warning | 03-31-22 |
Yescarta
The Food and Drug Administration (FDA) approved Yescarta® (axicabtagene ciloleucel for intravenous infusion) for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. Source: FDA website
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Expanded Indication | 04-01-22 |
Igalmi
The Food and Drug Administration (FDA) approved IgalmiTM (dexmedetomidine sublingual film) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Source: FDA website
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New Formulation | 04-05-22 |
Vijoice
The Food and Drug Administration (FDA) approved Vijoice® (alpelisib tablets) for the treatment of adult and pediatric individuals 2 years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Source: FDA website
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New Formulation | 04-05-22 |
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin extended-release tablet) to reduce the risk of sustained estimated glomerular filtration rate decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Source: FDA website
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Expanded Indication | 04-11-22 |
Insulin glargine
Mylan Pharmaceuticals announced a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin Source: FDA website
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Drug Recall | 04-13-22 |
Zerbaxa
The Food and Drug Administration (FDA) approved Zerbaxa® (ceftolozane sulfate/tazobactam sodium injection) in pediatric individuals from birth to less than 18 years of age for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI). Source: FDA website
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Expanded Indication | 04-21-22 |
Ultomiris
The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab-cwvz injection) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Source: FDA website
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New Indication | 04-27-22 |
Epsolay
The Food and Drug Administration (FDA) approved Epsolay® (benzoyl peroxide cream) for the treatment of inflammatory lesions of rosacea in adults. Source: FDA website
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New Formulation | 04-22-22 |
Cuvrior
The Food and Drug Administration (FDA) approved CuvriorTM (trientine tetrahydrochloride tablets) for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine. Source: FDA website
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New Formulation | 04-28-22 |
Vivjoa
The Food and Drug Administration (FDA) approved VivjoaTM (oteseconazole capsules) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. Source: FDA website
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New Drug | 04-27-22 |
Camzyos
The Food and Drug Administration (FDA) approved CamzyosTM (mavacamten capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Source: FDA website
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New Drug | 04-28-22 |
Accupril
Pfizer announced a voluntary recall of five lots of Accupril due to the presence of a nitrosamine above the acceptable level. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content Source: FDA website
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Drug Recall | 04-23-22 |