Drug Approvals Quarterly Update: January 2024

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
gepirone	Exxua^™	Fabre-Kramer	Major depressive disorder	September
lotilaner	Xdemvy^™	Tarsus	Demodex blepharitis	July
sotagliflozin	Inpefa^®	Lexicon	Reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits	May
nirmatrelvir and ritonavir tablets	Paxlovid^™	Pfizer	COVID-19	May
sulbactam/durlobactam	Xacduro^®	Entasis	Certain bacterial infections	May
perfluorohexyloctane	Miebo^™	Bausch + Lomb	Dry eye disease	May
fezolinetant	Veozah^™	Astellas	Vasomotor symptoms associated with menopause	May
rezafungin	Rezzayo^™	Melinta	Candidemia and invasive candidiasis	March
zavegepant	Zavzpret^™	Pfizer	Acute migraine	March
bexagliflozin	Brenzavvy^®	TheracosBio	Type 2 diabetes	January

Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.

Generic Name	Brand Name	Manufacturer	Indication(s)	Month Approved*
birch bark extract	Filsuvez^®	Chiesi	Epidermolysis bullosa	December
roflumilast foam	Zoryve^®	Arcutis	Seborrheic dermatitis of the scalp	December
heparin sodium; taurolidine	Defencath ™	Cormedix	Catheter related bloodstream infections	November
tirzepatide	Zepbound™	Eli Lilly	Obesity or overweight with cardiovascular risk factors	November
vonoprazan	Voquezna^®	Phathom	Erosive esophagitis	November
adapalene/benzoyl peroxide/ clindamycin	Cabtreo™	Bausch Health	Acne	October
tenapanor	Xphozah^®	Ardelyx	Hyperphosphatemia in chronic kidney disease	October
pilocarpine hydrochloride	Qlosi™	Orasis	Presbyopia	October
cantharidin	Ycanth^®	Verrica	Molluscum contagiosum	July
Magnesium sulfate sulfate, polyethylene glycol 3350, potassium chloride, sodium chloride, sodium sulfate	Suflave^®	Sebela	Bowel cleansing	June
aripiprazole 2-month, ready-to-use injectable	Abilify Asimtufii^®	Otsuka & Lundbeck	Schizophrenia, bipolar disorder	April
budesonide/formoterol fumarate	Symbicort Aerosphere^®	AstraZeneca	COPD	April

* Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.

Generic Name	Brand Name	Brand Manufacturer	Indication	Approval Month*
budesonide	Tarpeyo^®	Calliditas	Immunoglobulin A nephropathy (IgAN)	December
isavuconazonium sulfate	Cresemba^®	Astellas	Pediatrics with invasive aspergillosis or invasive mucormycosis (injection: 1 year of age and older; capsules: 6 years of age and older)	December
bupivacaine	Exparel^®	Pacira	Abductor canal block and sciatic nerve block	November
roflumilast	Zoryve^®	Arcutis	Plaque psoriasis in children ages 6-11 years	October
patiromer	Veltassa^®	Vifor	Patients aged 12 years and older with hyperkalemia	October
empagliflozin	Jardiance^®	Eli Lilly/ Boehringer Ingelheim	Chronic kidney disease	September
inclisiran	Leqvio^®	Novartis	Primary hyperlipidemia	July
levonorgestrel	Liletta^®	AbbVie	Heavy menstrual bleeding	June
empagliflozin	Jardiance^®	Eli Lilly/BI	Type 2 diabetes in children 10 years and older	June
empagliflozin/ metformin	Synjardy^®	Eli Lilly/BI	Type 2 diabetes in children 10 years and older	June
empagliflozin/ metformin	Synjardy^® XR	Eli Lilly/BI	Type 2 diabetes in children 10 years and older	June
abacavir/ dolutegravir/ lamivudine	Triumeq^®/ Triumeq PD	Viiv	HIV-1 in patients aged at least 3 months and weighing at least 6 kg	June
letermovir	Prevymis^®	Merck	Prevention of cytomegalovirus diseases in kidney transplant patients	June
linaclotide	Linzess^®	Abbie/Ironwood	Children 8-17 years of age with functional constipation	June
brexpiprazole	Rexulti^®	H. Lundbeck/ Otsuka	Agitation associated with dementia due to Alzheimer’s disease	May
dapagliflozin	Farxiga^®	AstraZeneca	To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure	May
escitalopram	Lexapro^®	Abbvie	Generalized anxiety disorder	May
fluticasone furoate/vilanterol	Breo^® Ellipta	GSK	Maintenance treatment of asthma in children 5-17 years of age	May
atogepant	Qulipta^®	AbbVie	Prevention of migraine	April

Generic Name	Brand Name	Brand Manufacturer	Indication	Approval Month*
chikungunya vaccine, live	Ixchiq^®	Valneva Austria	Prevention of disease caused by Chikungunya virus	November
meningococcal groups A, B, C, W, and Y vaccine	Penbraya™	Pfizer	Prevent invasive disease caused by Neisseria meningitidis	October
respiratory syncytial virus vaccine	Abrysvo™	Pfizer	Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in pregnant individuals at 32 through 36 weeks gestational age and severe LRTD caused by RSV in infants from birth through 6 months of age	August
nirsevimab-alip	Beyfortus™	Sanofi	Prevention of RSV lower respiratory tract disease	July
anthrax vaccine adsorbed, adjuvanted	Cyfendus™	Emergent Biosolutions	Post-exposure prophylaxis of disease following Bacillus anthracis exposure	July
respiratory syncytial virus vaccine, adjuvanted	Arexvy™	GSK	Prevention of LRTD caused by RSV in adults 60 years of age and above	May
respiratory syncytial virus vaccine, adjuvanted	Abrysvo™	Pfizer	Prevention of LRTD caused by respiratory syncytial virus (RSV) in adults 60 years of age and above	May

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved
eplontersen	Wainua™	AstraZeneca/Ionis	Familial amyloid polyneuropathy	IV/SC	December
immune globulin intravenous Human-stwk	Alyglo™	GC Biopharma	Primary immunodeficiency	IV	December
iptacopan	Fabhalta®	Novartis	Paroxysmal nocturnal hemoglobinuria	Oral	December
travoprost	iDose ® TR	Glaukos	Open-angle glaucoma or ocular hypertension	Intracameral implant	December
efbemalenograstim alfa-vuxw	Ryzneuta™	Evive	Chemotherapy- induced neutropenia	SC	November
ADAMTS13 recominant-krhn	Adzynma™	Takeda	Congenital thrombotic thrombocytopenic purpura	IV	November
infliximab-dyyb	Zymfentra®	Celltrion	Crohn’s disease	SC	October
mirikizumab-mrkz	Omvoh™	Eli Lilly	Ulcerative colitis	IV/SC	October
vamorolone	Agamree®	Santhera/Catalyst	Duchenne muscular dystrophy (DMD)	Oral	October
vosoritide	Voxzogo®	Biomarin	Achondroplasia	SC	October
bimekizumab-bkzx	Bimzelx®	UCB	Plaque psoriasis	SC	October
zilucoplan	Zilbrysq®	UCB	Myasthenia gravis	SC	October
etrasimod	Velsipity™	Pfizer	Ulcerative colitis	Oral	October
nedosiran	Rivfloza™	Novo Nordisk	Primary hyperoxaluria	SC	October
cipaglucosidase alfa-atga	Pombiliti™	Amicus	Pompe disease	IV	September
miglustat	Opfolda™	Amicus	Pompe disease	Oral	September
motixafortide	Aphexda®	BioLine Therapeutics	Hematopoietic stem cell mobilization	SC	September
zuranolone	Zurzuvae™	Sage	Postpartum depression	Oral	August
aflibercept	Eylea® HD	Regeneron	Diabetic macular edema; diabetic retinopathy; wet age-related macular degeneration (AMD)	Intravitreal	August
pozelimab-bbfg	Veopoz®	Regeneron	CD55-deficient protein-losing enteropathy (CHAPLE disease)	IV/SC	August
palovarotene	Sohonos®	Ipsen	Fibrodysplasia ossificans	Oral	August
avacincaptad pegol	Izervay®	Iveric	Geographic atrophy secondary to dry AMD	Intravitreal	August
somatrogon-ghla	Ngenla®	Pfizer	Pediatric growth hormone deficiency	SC	June
rozanolixizumab-noli	Rystiggo®	UCB	Generalized myasthenia gravis (gMG)	SC infusion	June
ritlecitinib	Litfulo®	Pfizer	Alopecia areata	Oral	June
efgartigimod alfa and hyaluronidase-qvfc	Vyvgart® Hytrulo	Argenx	gMG	SC	June
pegunigalsidase alfa- iwxj	Elfabrio®	Chiesi/Protalix	Fabry disease	IV	May
fecal microbiota spores live-brpk	Vowst®	Seres	Recurrent Clostridium difficile infection	Oral	April
tofersen	Qalsody®	Biogen	Superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis	Intrathecal	April
elexacaftor/tezacaftor/ ivacaftor and ivacaftor	Trikafta®	Vertex	Cystic fibrosis 2 through 5 years of age with at least one F508del mutation or a mutation that is responsive based on in vitro data	Oral	April
leniolisib	Joenja®	Pharming	Activated phosphoinositide 3-kinase delta syndrome (APDS)	Oral	March
trofinetide	Daybue®	Acadia	Rett syndrome	Oral	March
omaveloxolone	Skyclarys™	Reata	Friedreich’s ataxia	Oral	February
deutetrabenazine extended-release	Austedo™ XR	Teva	Tardive dyskinesia and chorea associated with Huntington disease	Oral	February
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl	Altuviiio™	Sanofi	Hemophilia A	IV	February
sparsentan	Filspari™	Travere	IgAN	Oral	February
velmanase alfa-tycv	Lamazede™	Chiesi	Alpha-mannosidosis	IV	February
pegcetacoplan	Syfovre™	Apellis	Geographic atrophy secondary to AMD	Intravitreal	February
daprodustat	Jesduvroq™	GSK	Anemia due to chronic kidney disease	Oral	February
lecanemab-irmb	Leqembi™	Eisai	Alzheimer's disease	IV	January
anacaulase-bcdb	NexoBrid™	MediWound	Burn tissue	Topical gel	January
sodium phenylbutyrate	Olpruva™	Acer	Urea cycle disorders	Oral	January

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Date Approved
eflonithine	Iwilfin®	US WorldMeds	Neuroblastoma	Oral	December
belzutifan	Welireg®	Merck	Renal cell cancer	Oral	December
nirogacestat	Ogsiveo®	Pfizer/ Springworks	Desmoid tumors	Oral	November
repotrectinib	Augtyro®	BMS	Non-small cell lung cancer (NSCLC)	Oral	November
fruquintinib	Fruzaqla®	Takeda	Colorectal cancer	Oral	November
capivasertib	Truqap®	AstraZeneca	Breast cancer (HR+/HER2-)	Oral	November
toripalimab-tpzi	Loqtorzi®	Coherus/Junshi	Nasopharyngeal cancer	IV	October
bosutinib	Bosulif®	Pfizer	Chronic myelogenous leukemia (CML)	Oral	September
momelotinib	Ojjaara®	GSK	Myelofibrosis with anemia	Oral	September 2023
melphalan	Hepzato® Kit	Delcath	Uveal melanoma	Hepatic arterial infusion	August
elranatamab-bcmm	Elrexfio®	Pfizer	Multiple myeloma	SC	August
abiraterone acetate/niraparib	Akeega®	Janssen	Prostate cancer	Oral	August
talquetamab-tgvs	Talvey®	Janssen	Multiple myeloma	SC	August
quizartinib	Vanflyta®	Daiichi Sankyo	Acute myeloid leukemia (AML)	Oral	July
glofitamab-gxbm	Columvi®	Genentech	Large B-cell lymphoma (LBCL)	IV	June
epcoritamab-bysp	Epkinly®	Genmab A/S	LBCL	SC	May
dabrafenib + trametinib	Tafinlar® + Mekinist®	Novartist/GSK	Pediatric patients with low-grade glioma (LGG) with a BRAF V600E mutation	Oral	March
retifanlimab-dlwr	Zynyz®	Incyte	Merkel cell carcinoma	IV	March
pirtobrutinib	Jaypirca®	Lilly	Mantle cell lymphoma	Oral	January
elacestrant	Orserdu®	Menarini/ Radius Health	Breast cancer (HR+/HER2-)	Oral	January

Generic Name	Brand Name	Manufacturer	New Indication(s)	Date Approved
immune globulin intravenous (human)	Bivigam^®	ADMA Biologics	Primary immunodeficiency for patients aged 2 years and older	December
coagulation Factor VIII (Human); von Willebrand Factor	Wilate^®	Octapharma	Prophylaxis of bleeding episodes in von Willebrand disease	December
tralokinumab-ldrm	Adbry^®	Leo	Patients 12-17 year of age with atopic dermatitis	December
secukinumab	Cosentyx^® SC	Novartis	Hidradenitis suppurativa (HS)	October
abatacept	Orencia^®	Bristol Myers Squibb (BMS)	Psoriatic arthritis (PsA) in pediatric patients 2 years of age and older	October
faricimab-svoa	Vabysmo^®	Genentech	Macular edema following retinal vein occlusion	October
etanercept	Enbrel	Amgen	Juvenile PsA in patients 2 years of age and older	October
secukinumab	Cosentyx^® IV	Novartis	IV formulation for PsA, ankylosing spondylitis and non-radiographic axial spondyloarthritis	October
valbenazine	Ingrezza^®	Neurocrine Biosciences	Chorea associated with Huntington’s disease	August
luspatercept-aamt	Reblozyl^®	BMS	Anemia due to myelodysplastic syndromes	August
odevixibat	Bylvay^®	Albireo	Alagille syndrome	June
upadacitinib	Rinvoq^®	AbbVie	Crohn's disease	May
ivacaftor	Kalydeco^®	Vertex	Cystic fibrosis patients with CFTR gene mutations	May
somapacitan-beco	Sogroya^®	Novo Nordisk	Children aged 2.5 years and older with growth failure	April
elexacaftor/tezacaftor/ ivacaftor and ivacaftor	Trikafta^®	Vertex	Cystic fibrosis 2 through 5 years of age with at least one F508del mutation or a mutation that is responsive based on in vitro data	April
immune globulin infusion; recombinant human hyaluronidase	HyQvia^®	Takeda	Primary immunodeficiency in children 2-16 years of age	April
maralixibat	Livmarli^®	Mirum	Cholestatic pruritis in Alagille syndrome (ALGS) in patients aged three months of age and older	March
sildenafil citrate oral suspension	Revatio^® oral suspension	Pfizer	Pulmonary arterial hypertension in patients aged 1 to 17 years and in patients too young to perform standardized testing	March
evinacumab-dgnb	Evkeeza^®	Regeneron	Children aged 5 to 11 years with homozygous familial hypercholesterolemia	March
sarilumab	Kevzara^®	Sanofi	Polymyalgia rheumatica	February
aflibercept	Eylea^®	Regeneron	Retinopathy of prematurity	February
abrocitinib	Cibinqo^®	Pfizer	Adolescents aged 12 to <18 years with AD	February
lanadelumab-flyo	Takhzyro^®	Shire	Prophylaxis to prevent attacks of hereditary angioedema (HAE) in children 2 to <12 years of age	February
tezepelumab-ekko	Tezspire^®	AstraZeneca/Amgen	Self-administration for severe asthma	February

Generic Name	Brand Name	Manufacturer	New Indication	Date Approved
pirtobrutinib	Jaypirca^®	Eli Lilly	Chronic lymphocytic leukemia (CLL)	December
enfortumab vedotin-ejfv	Padcev^®	Pfizer/Astellas	Urothelial cancer	December
enzalutamide	Xtandi ^®	Pfizer/Astellas	Prostate cancer	November
pembrolizumab	Keytruda^®	Merck	Gastric and gastroesophageal junction cancer	November
pembrolizumab	Keytruda^®	Merck	Biliary tract cancer	October
ivosidenib	Tibsovo^®	Servier	Myelodysplastic syndromes	October
pembrolizumab	Keytruda^®	Merck	NSCLC	October
nivolumab	Opdivo^®	BMS	Melanoma	October
pembrolizumab	Keytruda^®	Merck	Merkel cell carcinoma	October
encorafenib	Braftovi^®	Pfizer/Array	NSCLC	October
binimetinib	Mektovi^®	Pfizer/Array	NSCLC	October
temozolomide	Temodar^®	Merck	Anaplastic astrocytoma	September
luspartercept-aamt	Reblozyl^®	BMS	ESA-naïve anemia due to MDS	August
trametinib/dabrafenib	Mekinist^®/Tafinlar^®	Novartis	Solid tumors	August
trifluridine/tipiracil	Lonsurf^®	Taiho	Colorectal cancer in combination with bevacizumab	August
dostarlimab-gxly	Jemperli^®	GSK	Endometrial cancer	July
talazoparib tosylate	Talzenna^®	Pfizer	Prostate cancer	June
olaparib	Lynparza^®	AstraZeneca	Prostate cancer	June
enfortumab vedotin-ejfv	Padcev^®	Astellas/Pfizer	Urothelial cancer	April
pembrolizumab	Keytruda^®	Merck	Endometrial carcinoma	March
abemaciclib	Verzenio^®	Lilly	Breast cancer	March
sacituzumab govitecan-hziy	Trodelvy^®	Gilead	Breast cancer (HR+/HER2-)	February
pembrolizumab	Keytruda^®	Merck	NSCLC	January
tucatinib	Tukysa^®	Pfizer	Colorectal cancer	January
zanubrutinib	Brukinsa^®	BeiGene	CLL or small lymphocytic lymphoma	January

Generic Name	Brand Name	Reference Product	Manufacturer	Indication(s)	Route of Administration	Month Approved
bevacizumab-tnjn	Avzivi®	Avastin	Sandoz/Bio-Thera	Cancer	IV	December
ustekinumaab-auub	Wezlana™	Stelara	Amgen	Autoimmune	IV/SC	October
tocilizumab-bavi	Tofidence™	Actemra	Biogen/Bio-Thera	Autoimmune	IV	September
natalizumab-sztn	Tyruko™	Tysabri®	Polpharma/Sandoz	Multiple Sclerosis and Crohn’s disease	IV	August
adalimumab-aaty	Yuflyma®	Humira®	Celltrion	Autoimmune	SC	May

Generic Name	Brand Name	Manufacturer	Indication(s)	Route of Administration	Month Approved
lovotibeglogene autotemcel	Lyfgenia™	bluebird bio	Sickle cell disease	IV	December
exagamglogene autotemcel	Casgevy™	Vertex/CRISPR	Sickle cell disease	IV	December
valoctocogene roxaparvovec-rvox	Roctavian™	BioMarin	Severe hemophilia A	IV	June
delandistrogene moxeparvovec-rokl	Elevidys^®	Sarepta	Duchenne muscular dystrophy (DMD) (4-5 years of age)	IV	June
donislecel-jujn	Lantidra^®	CellTrans	Uncontrolled type 1 diabetes	Hepatic portal vein	June
beremagene geperpavec-svdt	Vyjuvek^®	Krystal Biotech	Dystrophic epidermolysis bullosa (DEB)	Topical	May
omidubicel-onlv	Omisirge™	Gamida Cell	Blood cancers in need of allogeneic hematopoietic stem cell transplant (HSCT)	IV	April

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