Perspectives
Drug Approvals Quarterly Update: January 2024
January 31, 2024This 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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