Drug Approvals Quarterly Update: January 2024

January 31, 2024

This wrap-up provides a review of newly approved drugs, recent drug launches, new indications and news of note on drugs in the approval process.

Traditional drug approvals

New molecular entity traditional approvals – 2023

New molecular entity traditional approvals – 2023

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.
Other new product approvals – 2023
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.

New indications for approved traditional medications – 2023
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
Vaccine and immunization new approvals – 2023
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

 

Specialty drug approvals

Specialty new product approvals – 2023
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  

 

Oncology product approvals – 2023
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  
New indications for approved specialty products – 2023
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

Biosimilars and gene/cell therapy drug approvals

New indications for approved oncology drugs – 2023
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
Biosimilar product full approvals in the past twelve months
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  
FDA approved gene/cell therapy products in the last 12 months
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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