January | February | March | April | May | June | July | August | September | October | November | December |
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Drug | Description | FDA approved use | Company | FDA filing | Pathway | Date |
Airsupra (PT-027) | Metered-dose inhaler; fixed-dose combination rescue medication containing albuterol and budesonide | Asthma | Astrazeneca plc, of Cambridge, U.K., and Avillion LLP, of London | NDA | Standard | 1/10/2023 |
Brenzavvy (bexagliflozin) | Oral SGLT2 inhibitor | Type 2 Diabetes | Theracosbio Inc., of Marlborough, Mass. | NDA | NME; standard | 1/20/2023 |
Brukinsa (zanubrutinib) | BTK inhibitor | Chronic lymphocytic leukemia or small lymphocytic lymphoma | Beigene Ltd., of Beijing | sNDA | N/A | 1/19/2023 |
Jaypirca (pirtobrutinib) | Next-gen BTK inhibitor | Mantle cell lymphoma | Loxo Oncology Inc., of Stamford, Connecticut | NDA | Accelerated; priority; orphan; NME | 1/27/2023 |
Keytruda (pembrolizumab) | Monoclonal antibody targeting PD-1 | Non-small-cell-lung cancer | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 1/27/2023 |
Leqembi (lecanemab) | Anti-amyloid beta protofibril antibody | Alzheimer's disease | Eisai Co. Ltd., of Tokyo | BLA | Accelerated; priority; NME | 1/6/2023 |
Odactra | House dust mite allergen extract tablet for sublingual use | House dust mite-induced allergic rhinitis | Alk-Abello Inc., of Round Rock, Texas | sBLA | N/A | 1/25/2023 |
Orserdu (elacestrant) | Oral SERD therapy | ER+/HER2-negative advanced or metastatic breast cancer | Menarini Group, of Florence, Italy | NDA | Priority; NME | 1/30/2023 |
Rykindo (risperidone) | Extended-release injectable suspension | Schizophrenia and bipolar I disorder | Luye Pharma Group Ltd., of Shanghai | NDA | Standard | 1/13/2023 |
Tukysa (tucatinib) | HER2 tyrosine kinase inhibitor | RAS wild-type HER2-positive unresectable or metastatic colorectal cancer | Seagen Inc., of Bothell, Wash. | sNDA | Priority; accelerated | 1/19/2023 |
Altuviiio (Efanesoctocog alfa) | Recombinant factor VIII therapy | Hemophilia A | Sanofi SA, of Paris, and Swedish Orphan Biovitrum AB, of Stockholm | BLA | Priority; fast track; breakthrough | 2/23/2023 |
Austedoxr (deutetrabenazine) | Once-daily formulation; vesicular monoamine transporter 2 inhibitor | Tardive dyskinesia and chorea associated with Huntington's disease | Teva Pharmaceuticals, of Tel Aviv, Israel, and Parsippany, N.J. | sNDA | N/A | 2/17/2023 |
Cibinqo (abrocitinib) | JAK1 inhibitor | Moderate to severe atopic dermatitis | Pfizer Inc., of New York | sNDA | N/A | 2/9/2023 |
Eylea/aflibercept | VEGF inhibitor | Retinopathy of prematurity | Regeneron Pharmaceuticals Inc., of Tarrytown, New York | sBLA | Priority | 2/8/2023 |
Filspari (Sparsentan) | Dual endothelin angiotensin receptor antagonist | IgA Nephropathy | Travere Therapeutics Inc., of San Diego | NDA | Accelerated; priority; NME | 2/17/2023 |
Jemperli (dostarlimab) | Anti-PD-1 inhibitor | Mismatch repair-deficient recurrent or advanced endometrial cancer | GSK plc, of London | sBLA | N/A | 2/9/2023 |
Jesduvroq (daprodustat) | Oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor | Chronic kidney disease-related anemia | GSK plc., of London | NDA | NME; standard | 2/1/2023 |
Kevzara (sarilumab) | Inhibits IL-6-mediated signaling | Polymyalgia rheumatica | Regeneron Pharmaceuticals Inc., of Tarrytown, N.J. | sBLA | N/A | 2/28/2023 |
Lamzede ERT | Enzyme replacement therapy | Alpha-mannosidosis | Chiesi Farmaceutici SpA, of Italy | BLA | Orphan; NME | 2/16/2023 |
Skyclarys (omaveloxolone) | Second-generation member of the synthetic oleanane triterpenoid | Friedreich’s ataxia | Reata Pharmaceuticals Inc., of Plano, Texas | NDA | NME; priority | 2/28/2023 |
Syfovre (pegcetacoplan injection) | Intravitreal targeted C3 therapy | Geographic atrophy secondary to age-related macular degeneration | Apellis Pharmaceuticals Inc., of Waltham, Mass. | NDA | Priority | 2/17/2023 |
Takhzyro (lanadelumab-flyo) | Plasma kallikrein inhibitor | Hereditary angioedema attacks in children 2 and older | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | sBLA | N/A | 2/3/2023 |
Tezspire (tezepelumab) | Monoclonal antibody inhibiting action of TSLP | Severe asthma | Astrazeneca plc, of Cambridge, U.K., and Amgen Inc., of Thousand Oaks, Calif. | sBLA | N/A | 2/2/2023 |
Trodelvy (sacituzumab govitecan) | Antibody-drug conjugate targeting Trop-2 | HR+/HER2-negative metastatic breast cancer | Gilead Sciences Inc., of Foster City, Calif. | sBLA | Priority | 2/3/2023 |
Citrate-free high-concentration formulation of adalimumab | Biosimilar Hyrimoz (adalimumab-adaz) | Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis | Sandoz AG, of Basel, Switzerland | sBLA | N/A | 3/21/2023 |
Daybue (trofinetide) | Synthetic analogue of amino?terminal tripeptide of IGF-1 | Rett syndrome | Acadia Pharmaceuticals Inc., of San Diego | NDA | NME; priority | 3/10/2023 |
Evkeeza (evinacumab) | Angiopoietin-related protein-3 inhibitor | Homozygous familial hypercholesterolemia | Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | sBLA | Priority | 3/22/2023 |
Joenja (leniolisib) | Small-molecule phosphoinositide 3-kinase delta inhibitor | Activated phosphoinositide 3-kinase delta syndrome | Pharming Group NV, of Leiden, the Netherlands | NDA | NME; standard | 3/24/2023 |
Keytruda (pembrolizumab) | Monoclonal antibody targeting PD-1 | Unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 3/29/2023 |
Livmarli (maralixibat) | Ileal bile acid transporter inhibitor; oral solution | Cholestatic pruritus in patients with Alagille syndrome | Mirum Pharmaceuticals Inc., of Foster City, Calif. | sNDA | N/A | 3/13/2023 |
M-M-RII; Varivax; Proquad | Vaccines | Prevention of measles, mumps and rubella; prevention of varicella; prevention of measles, mumps, rubella and varicella | Merck & Co. Inc., of Rathway, N.J. | sBLA | N/A | 3/6/2023 |
Nelarabine | Prodrug of the deoxyguanosine analogue 9-?-D- arabinofuranosylguanine (ara-G) | T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma | Shorla Oncology Inc., of Cambridge, Mass. | ANDA | Standard | 3/7/2023 |
Rezzayo (Rezafungin) | Once-weekly echinocandin; antifungal | Candidemia and invasive candidiasis | Cidara Therapeutics Inc., of San Diego | NDA | Priority; NME | 3/22/2023 |
Tafinlar (dabrafenib) and Mekinist (trametinib) | BRAF inhibitor and MEK inhibitor | Low-grade glioma with a BRAF V600E mutation | Novartis AG, of Basel, Switzerland | sNDA | Accelerated | 3/17/2023 |
Udenyca (pegfilgrastim-cbqv) | Single-dose, prefilled autoinjector; biosimilar pegfilgrastim | Cancer patients receiving myelosuppressive chemotherapy | Coherus Biosciences Inc., of Redwood City, Calif. | sBLA | N/A | 3/3/2023 |
Verzenio (abemaciclib) | CDK4/6 inhibitor; non-chemotherapy oral tablet | HR+, HER2-, node-positive early breast cancer | Eli Lilly and Co., of Indianapolis | sNDA | N/A | 3/3/2023 |
Zavzpret (zavegepant) | CGRP receptor antagonist; nasal spray | Migraine | Pfizer Inc., of New York | NDA | NME; standard | 3/10/2023 |
Zynyz (retifanlimab-dlwr) | Humanized monoclonal antibody targeting PD-1 | Metastatic or recurrent locally advanced Merkel cell carcinoma | Incyte Corp., of Wilmington, Del. | BLA | Orphan; NME | 3/22/2023 |
Abilify Asimtufii (aripiprazole) | Extended-release injectable suspension for intramuscular use | Schizophrenia and bipolar I disorder | Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Valby, Denmark | NDA | Standard | 4/27/2023 |
Hyqvia (human normal immunoglobulin 10% and recombinant human hyaluronidase) | Subcutaneous immunoglobulin replacement therapy | Primary immunodeficiency | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan | sBLA | N/A | 4/11/2023 |
Omisirge (omidubicel-onlv) | Advanced cell therapy | Hematologic malignancies planned for umbilical cord blood transplantation | Gamida Cell Ltd., of Boston | BLA | Priority;breakthrough;orphan | 4/17/2023 |
Padcev (enfortumab vedotin) | Antibody-drug conjugate targeting Nectin-4 | Locally advanced or metastatic urothelial cancer | Seagen Inc., of Bothell, Wash., and Astellas Pharma Inc., of Tokyo | sBLA | Accelerated; priority | 4/3/2023 |
Polivy (polatuzumab vedotin) | Anti-CD79b antibody-drug conjugate | Diffuse large B-cell lymphoma | Genentech Inc., of South San Francisco, a member of the Roche Group | sBLA | N/A | 4/19/2023 |
Prevnar-20 | 20-valent pneumococcal conjugate vaccine | Prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes | Pfizer Inc., of New York | sBLA | N/A | 4/27/2023 |
Prevnar-20 | 20-valent pneumococcal conjugate vaccine | Prevention of otitis media | Pfizer Inc., of New York | sBLA | N/A | 4/27/2023 |
Qalsody (tofersen) | Antisense oligonucleotide binds to SOD1 mRNA | Amyotrophic lateral sclerosis | Biogen Inc., of Cambridge, Mass. | NDA | Priority; orphan; fast track; Accelerated; NME | 4/25/2023 |
Qulipta (atogepant) | CGRP antagonist | Migraine | Abbvie Inc., of North Chicago | sNDA | N/A | 4/17/2023 |
Rizafilm | Oral film | Acute migraine | Intelgenx Corp., of Quebec | NDA | 505(b)(2) | 4/14/2023 |
Uzedy | Extended-release injectable suspension of risperidone | Schizophrenia | Teva Pharmaceuticals Ltd., of Tel Aviv-Yafo, Israel, and Medincell SA, of Jacou, France | NDA | Standard | 4/28/2023 |
Vowst (SER-109) | Oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores | Recurrent Clostridium difficile infection | Seres Therapeutics Inc., of Cambridge, Mass. | BLA | Priority;Breakthrough;Orphan | 4/26/2023 |
Abrysvo (RSVpreF; PF-06928316) | RNA vaccine | RSV lower respiratory tract disease | Pfizer Inc., of New York | BLA | Priority; Fast track;Breakthrough | 5/31/2023 |
Arexvy (adjuvanted RSVPreF3 OA) | Respiratory syncytial virus vaccine | RSV infection prophylaxis | GSK plc, of London | BLA | Priority | 5/3/2023 |
Ayvakit (avapritinib) | Kinase inhibitor | Indolent systemic mastocytosis | Blueprint Medicines Corp., of Cambridge, Mass. | sNDA | N/A | 5/22/2023 |
Brixadi (buprenorphine) | Mu-opioid receptor agonist; delta-opioid and kappa-opioid receptor antagonist; extended-release weekly and monthly subcutaneous injections | Moderate to severe opioid use disorder | Braeburn Inc., of Plymouth Meeting, Pa. | NDA | Priority | 5/23/2023 |
Cyltezo (adalimumab-adbm) | Pen autoinjector ; biosimilar to Humira | Multiple chronic inflammatory diseases | Boehringer Ingelheim GmbH, of Ingelheim, Germany | sBLA | N/A | 5/18/2023 |
Elfabrio (pegunigalsidase alfa-iwxj) | Modified stabilized version of the recombinant human alpha-galactosidase A protein | Fabry disease | Protalix Biotherapeutics Inc., of Carmiel, Israel, and Chiesi Global Rare Diseases, a business unit of Parma, Italy-based Chiesi Farmaceutici SpA | BLA | N/A | 5/9/2023 |
Epkinly (epcoritamab) | IgG1-bispecific antibody CD3xCD20 | Relapsed/refractory diffuse large B-cell lymphoma | Abbvie Inc., of North Chicago, and Genmab A/S of Copenhagen, Denmark | BLA | NME; priority; accelerated | 5/19/2023 |
Farxiga (dapagliflozin) | Oral, once-daily SGLT2 inhibitor | Heart failure | Astrazeneca plc, of Cambridge, U.K. | sNDA | N/A | 5/8/2023 |
Injectafer | Ferric carboxymaltose injection | Iron deficiency in adults with heart failure | Daiichi Sankyo Inc., of Basking Ridge, N.J., and American Regent Inc., a unit of Daiichi | sNDA | N/A | 5/31/2023 |
Inpefa (sotagliflozin) | SGLT1 and SGLT2 inhibitor | Heart failure | Lexicon Pharmaceuticals, Inc., of The Woodlands, Texas | NDA | NME; Standard | 5/26/2023 |
Kalydeco (ivacaftor) | CFTR stimulator | Cystic fibrosis | Vertex Pharmaceuticals Inc., of Boston | sNDA | N/A | 5/3/2023 |
Lumryz (FT-218) | Extended release formulation of sodium oxybate | Excessive daytime sleepiness or cataplexy in adults with narcolepsy | Avadel Pharmaceuticals plc, of Dublin | NDA | Standard;orphan | 5/1/2023 |
Miebo (perfluorohexyloctane) | Ophthalmic liquid formulation | Dry eye disease associated with Meibomian gland dysfunction | Bausch + Lomb, unit of Bausch Health Cos. Inc., of Laval, Quebec, and Novaliq GmbH, of Heidelberg, Germany | NDA | NME; Standard | 5/18/2023 |
Opvee | Nasal spray of nalmefene | Known or suspected opioid overdose induced by natural or synthetic opioids | Indivior plc, of Richmond, Va. | NDA | Priority | 5/22/2023 |
Rexulti (brexpiprazole) | Partial agonist of serotonin 5-HT1A and dopamine D2 receptors | Agitation associated with Alzheimer’s dementia | Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Valby, Denmark | sNDA | Priority | 5/10/2023 |
Veozah (fezolinetant) | Neurokinin-3 receptor antagonist | Moderate to severe vasomotor symptoms due to menopause | Astellas Pharma Inc., of Tokyo | NDA | Priority | 5/12/2023 |
Vevye | Cyclosporine ophthalmic solution 0.1% | Dry eye disease | Novaliq GmbH, of Heidelberg, Germany | NDA | Standard | 5/31/2023 |
Vyjuvek (beremagene geperpavec, or B-VEC) | Topical gene therapy | Dystrophic epidermolysis bullosa | Krystal Biotech Inc., of Pittsburgh | BLA | Priority; orphan; rare pediatric disease | 5/19/2023 |
Xacduro (sulbactam-durlobactam) | Intravenous combination of beta-lactam antibiotic and broad-spectrum beta-lactamase inhibitor | Infections caused by Acinetobacter baumannii-calcoaceticus complex | Entasis Therapeutics Inc., of Waltham, Mass. | NDA | Fast Track; Qualified Infectious Disease Product; Priority | 5/23/2023 |
Yuflyma (CT-P17) | Adalimumab biosimilar with a high-concentration, low-volume and citrate-free formulation | Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa | Celltrion Healthcare Inc., of Incheon, South Korea | BLA | N/A | 5/23/2023 |
Blincyto (blinatumomab) | Bispecific T-cell engager immuno-oncology therapy | CD19-positive B-cell precursor acute lymphoblastic leukemia | Amgen Inc., of Thousand Oaks, Calif. | sBLA | N/A | 6/21/2023 |
Bylvay (odevixibat)? | IBAT inhibitor | Cholestatic pruritus due to Alagille syndrome | Albireo Pharma Inc., of Boston | sNDA | N/A | 6/13/2023 |
Camzyos (mavacamten) | Myosin inhibitor | Obstructive hypertrophic cardiomyopathy | Bristol Myers Squibb & Co., of New York | sNDA | N/A | 6/15/2023 |
Columvi (glofitamab-gxbm) | CD20xCD3 T-cell engaging bispecific antibody | Relapsed or refractory large B-cell lymphoma | Genentech Inc., a unit of Roche Holding AG, of Basel, Switzerland | BLA | Priority;accelerated | 6/15/2023 |
Elevidys (delandistrogene moxeparvovec) | Gene therapy | Duchenne muscular dystrophy | Sarepta Therapeutics Inc., of Cambridge, Mass. | BLA | Priority;accelerated;rare pediatric disease | 6/22/2023 |
Jardiance and Synjardy | Empagliflozin and empagliflozin and metformin hydrochloride | Type 2 diabetes | Boehringer Ingelheim GmbH, of Ingelheim, Germany | sNDA | Priority | 6/20/2023 |
Lantidra (donislecel) | Cell therapy | Type 1 diabetes | Celltrans Inc., of Chicago | BLA | N/A | 6/29/2023 |
Linzess (linaclotide) | Guanylate cyclase-C agonist | Functional constipation | Ironwood Pharmaceuticals Inc., of Boston | sNDA | Priority | 6/12/2023 |
Litfulo (ritlecitinib) | A once-daily oral treatment | Severe alopecia areata | Pfizer Inc., of New York | NDA | NME;standard | 6/23/2023 |
Lodoco | Anti-inflammatory atheroprotective cardiovascular treatment | Atherosclerotic disease or at risk for cardiovascular disease | Agepha Pharma USA LLC, of Parisippany, N.J. | NDA | Priority | 6/16/2023 |
Lynparza (olaparib) | Poly (ADP-ribose) polymerase inhibitor | Deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer | Astrazeneca plc, of Cambridge, Mass., and Merck & Co. Inc., of Rahway, N.J. | sNDA | N/A | 6/1/2023 |
Ngenla (somatrogon-ghla) | A once weekly, human growth hormone analog | Growth hormone deficiency | Pfizer Inc., of New York, and Opko Health Inc., of Miami | NDA | N/A | 6/28/2023 |
Prevymis (letermovir) | First-in-class non-nucleoside cytomegalovirus inhibitor | Cytomegalovirus prophylaxis in adult kidney transplant recipients | Merck & Co. Inc., of Rahway, N.J. | sNDA | Priority | 6/5/2023 |
Roctavian (Valoctocogene roxaparvovec) | Adeno-associated virus vector encoding human coagulation factor VIII | Severe hemophilia A | Biomarin Pharmaceutical Inc., of San Rafael, Calif. | BLA | N/A | 6/29/2023 |
Rystiggo (rozanolixizumab-noli) | Subcutaneous monoclonal antibody targeting the neonatal Fc receptor | Generalized myasthenia gravis | UCB SA, of Brussels | BLA | Priority | 6/27/2023 |
Skyclarys (omaveloxolone) | Second-generation member of the synthetic oleanane triterpenoid | Friedreich's ataxia | Reata Pharmaceuticals Inc., of Plano, Texas | sNDA | Prior approval supplement | 6/27/2023 |
Talzenna (talazoparib) and Xtandi (enzalutamide) | An oral poly ADP-ribose polymerase inhibitor | Homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer | Pfizer Inc., of New York | sNDA | N/A | 6/20/2023 |
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) | Subcutaneous version of human IgG1; delivered with Enhanze drug delivery technology (Halozyme Therapeutics Inc.) | Generalized myasthenia gravis | Argenx SE, of Amsterdam | BLA | Priority | 6/20/2023 |
Balfaxar (prothrombin complex concentrate, human-lans) | Non-activated four factor prothrombin complex concentrate (4F-PCC) therapy | Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy | Octapharma USA Inc., of Paramus, N.J. | BLA | N/A | 7/26/2023 |
Beyfortus (nirsevimab) | Fully recombinant human immunoglobulin G1 kappa monoclonal antibody | Respiratory syncytial virus | Sanofi SA, of Paris and Astrazeneca plc, of Cambridge, U.K. | BLA | Fast Track; Breakthrough | 7/17/2023 |
Cyclophosphamide injection | 200mg/mL vials | Various types of cancer | Nevakar Injectables Inc., of Bridgewater, N.J. | NDA | N/A | 7/3/2023 |
Cyfendus (AV-7909) | Anthrax vaccine adsorbed, adjuvanted | Post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis | Emergent Biosolutions Inc., of Gaithersburg, Md. | BLA | N/A | 7/20/2023 |
Ervebo | Ebola Zaire vaccine, live | Zaire ebolavirus | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 7/28/2023 |
Jemperli (dostarlimab-gxly) | Anti-PD-1 inhibitor | Mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer | Anaptysbio Inc., of San Diego, and GSK plc, of London | sBLA | Priority | 7/31/2023 |
Leqembi (lecanemab-irmb) | 100 mg/mL injection; humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta (A?) | Alzheimer's disease | Bioarctic AB, of Stockholm, and Eisai Co. Ltd., of Tokyo | sBLA | N/A | 7/7/2023 |
Opill | Progestin-only daily pill | Birth control | Perrigo Co. plc, of Dublin | sNDA | N/A | 7/13/2023 |
Rivive | Naloxone HCl nasal spray 3 mg | Opioid overdose | Harm Reduction Therapeutics Inc., of Pittsburgh | NDA | N/A | 7/28/2023 |
Vanflyta (quizartinib) | FLT3 inhibitor | Acute myeloid leukemia | Daiichi Sankyo Co. Ltd., of Tokyo | NDA | Priority;NME;Orphan | 7/20/2023 |
Veklury (remdesivir) | Viral RNA polymerase | COVID-19 patients with severe renal impairment | Gilead Sciences Inc., of Foster City, Calif. | sNDA | N/A | 7/14/2023 |
Xdemvy | Lotilaner ophthalmic solution, 0.25% | Demodex blepharitis | Tarsus Pharmaceuticals Inc., of Irvine, Calif. | NDA | NME;standard | 7/24/2023 |
Ycanth (cantharidin) topical solution | Cantharidin 0.7% topical solution | Molluscum contagiosum | Verrica Pharmaceuticals Inc., of West Chester, Pa. | NDA | Priority | 7/21/2023 |
Abrysvo (RSVpreF) | Vaccine | Respiratory syncytial virus | Pfizer Inc., of New York | BLA | N/A | 8/22/2023 |
Daxxify (daxibotulinumtoxinA-lanm) | Peptide formulated neuromodulator | Cervical dystonia | Revance Therapeutics Inc., of Nashville, Tenn. | sBLA | N/A | 8/14/2023 |
Elrexfio (elranatamab-bcmm) | BCMAxCD3-targeted bispecific antibody | Relapsed or refractory multiple myeloma | Pfizer Inc., of New York | BLA | Accelerated;orphan;Priority | 8/14/2023 |
Eylea HD (aflibercept)/ 8 mg for injection | VEGF inhibitor | Wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy | Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | BLA | N/A | 8/18/2023 |
Ingrezza (valbenazine) capsules | VMAT2 inhibitor | Chorea associated with Huntington disease | Neurocrine Biosciences Inc., of San Diego | sNDA | N/A | 8/18/2023 |
Izervay (avacincaptad pegol) | Complement C5 inhibitor (formerly Zimura) | Geographic atrophy | Iveric Bio Inc., of Parsippany, N.J. | NDA | Priority;Fast track;Breakthrough | 8/4/2023 |
Lonsurf (trifluridine/tipiracil) | Thymidine-based nucleoside analogue and thymidine phosphorylase inhibitor | Metastatic colorectal cancer | Taiho Oncology Inc. and Taiho Pharmaceutical Co. Ltd., of Princeton, N.J. | sNDA | Priority | 8/2/2023 |
Reblozyl (luspatercept-aamt) | Erythroid maturation agent | Anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes | Bristol Myers Squibb Co., of New York | sBLA | N/A | 8/28/2023 |
Sohonos (palovarotene) | Selective retinoic-acid receptor gamma agonist | Fibrodysplasia ossificans progressiva | Ipsen SA, of Paris | NDA | Breakthrough;orphan;priority;NME | 8/16/2023 |
Talvey (talquetamab-tgvs) | Bispecific GPRC5D-directed CD3 T-cell engager | Relapsed or refractory multiple myeloma | Janssen Research & Development LLC, part of Johnson & Johnson, of New Brunswick, N.J. | BLA | Accelerated;orphan | 8/9/2023 |
Tyruko (natalizumab-sztn) | Biosimilar; anti-?4 integrin monoclonal antibody | Relapsing forms of multiple sclerosis | Sandoz AG, a unit of Novartis AG, of Basel, Switzerland | BLA | N/A | 8/24/2023 |
Veopoz (pozelimab-bbfg) | C5 antibody | Chaple disease | Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. | BLA | Priority; rare pediatric disease; orphan; fast track | 8/18/2023 |
Zurzuvae (zuranolone) | Neuroactive steroid; positive allosteric modulator of GABA-A receptors | Postpartum depression | Sage Therapeutics Inc., Cambridge, Mass. | NDA | Priority;Fast track;Breakthrough | 8/4/2023 |
Abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg | Tablets for oral suspension; fixed-dose combination containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor | HIV-1 infection in pediatric patients | Viatris Inc., of Canonsburg, Pa. | NDA | N/A | 9/6/2023 |
Comirnaty 2023-2024 formulation | Omicron XBB.1.5-adapted monovalent COVID-19 vaccine | COVID-19 | Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany | sBLA | N/A | 9/11/2023 |
Entyvio (vedolizumab) | Subcutaneous administration; single-dose prefilled pen; inhibits alpha4beta7 integrin | Moderately to severely active ulcerative colitis | Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Cambridge, Mass. | BLA | N/A | 9/27/2023 |
Exxua (gepirone hydrochloride extended-release tablets) | Novel oral selective serotonin (5HT) 1a receptor agonist | Fabre-Kramer Pharmaceuticals Inc., of Houston | NDA | NME;standard | 9/22/2023 | |
Jardiance (empagliflozin) | Oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor | Chronic kidney disease | Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis | sNDA | N/A | 9/22/2023 |
Likmez (ATI-1501) metronidazole oral suspension | Taste-masked liquid suspension reformulation of metronidazole | Parasitic and anaerobic bacterial infections | Appili Therapeutics Inc., of Halifax, Nova Scotia | NDA | Standard;Orphan;505(b)(2) | 9/22/2023 |
Motixafortide/Aphexda | Stem cell mobilization agent | Multiple myeloma | Biolinerx Ltd., of Tel Aviv, Israel | NDA | NME;standard | 9/8/2023 |
mRNA-1273.214 (Spikevax bivalent original/omicron) | Omicron-containing bivalent booster vaccine with spike proteins for the XBB.1.5 sublineage | COVID-19 | Moderna Inc., of Cambridge, Mass. | sBLA | N/A | 9/11/2023 |
Ojjaara (Momelotinib ) | ACVR1 / ALK2, JAK1 and JAK2 inhibitor | Myelofibrosis patients with anaemia | GSK plc, of London | NDA | NME;standard | 9/15/2023 |
Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) | Bis-M6P-enriched rhGAA + enzyme stabilizer | Pompe disease | Amicus Therapeutics Inc., of Philadelphia | BLA | Breakthrough;orphan | 9/28/2023 |
Rivfloza (nedosiran) | RNAi therapy | Primary hyperoxaluria type 1 | Novo Nordisk A/S, of Bagsvaerd, Denmark | NDA | NME;Priority | 9/29/2023 |
Ryzumvi (phentolamine ophthalmic solution) | Preservative-free, ophthalmic formulation of phentolamine mesylate; non-selective alpha-1 and alpha-2 adrenergic antagonist | Pharmacologically induced mydriasis | Ocuphire Pharma Inc., of Farmington Hills, Mich. | NDA | Standard | 9/25/2023 |
Talicia | Fixed-dose oral capsule combination of 2 antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor | Helicobacter pylori infection | Redhill Biopharma Ltd., of Tel Aviv, Israel | sNDA | N/A | 9/18/2023 |
Tofidence (tocilizumab-bavi) | Intravenous formulation; biosimilar monoclonal antibody referencing Actemra (tocilizumab; Roche AG) | Moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis | Biogen Inc., of Cambridge, Mass. | BLA | N/A | 9/28/2023 |
Agamree (vamorolone) oral suspension | Dissociative anti-inflammatory drug | Duchenne muscular dystrophy | Santhera Pharmaceuticals, of Pratteln, Switzerland, and Reveragen Biopharma Inc., of Rockville, Md. | NDA | NME;Priority | 10/26/2023 |
Bimzelx (bimekizumab-bkzx) | Monoclonal antibody targeting IL-17A and IL-17F | Moderate to severe plaque psoriasis | UCB SA, of Brussels | BLA | N/A | 10/18/2023 |
Braftovi (encorafenib) and Mektovi (binimetinib) | Kinase inhibitors | Metastatic non-small-cell lung cancer | Pfizer Inc., of New York | sNDA | N/A | 10/11/2023 |
Byooviz (ranibizumab-nuna) | Biosimilar product interchangeable with Lucentis (ranibizumab); anti-VEGF | Wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization | Samsung Bioepis Co. Ltd., of Incheon, Korea | sBLA | N/A | 10/24/2023 |
Cortrophin Gel | 1-mL vial (80 USP units/1 mL) of purified cortrophin gel (repository corticotropin injection USP) | Acute gouty arthritis | ANI Pharmaceuticals Inc., of Baudette, Minn. | sNDA | N/A | 10/2/2023 |
Cosentyx (secukinumab) | Fully human biologic that directly inhibits interleukin-17A | Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis | Novartis AG, of Basel, Switzerland | sBLA | N/A | 10/6/2023 |
Cosentyx (secukinumab) | Fully human biologic that directly inhibits interleukin-17A | Moderate to severe hidradenitis suppurativa | Novartis AG, of Basel, Switzerland | sBLA | N/A | 10/31/2023 |
Keytruda (pembrolizumab) | Monoclonal antibody targeting PD-1 | Resectable stage II, IIIA or IIIB non-small cell lung cancer | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 10/16/2023 |
Keytruda (pembrolizumab) | Anti-PD-1 therapy | Advanced or unresectable biliary tract cancer | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 10/31/2023 |
Loqtorzi (toripalimab) | PD-1 inhibitor antibody | Nasopharyngeal carcinoma | Coherus Biosciences Inc., of Redwood City, Calif. | BLA | Orphan | 10/27/2023 |
Maxigesic I.V. | Combination of 1,000-mg paracetamol and 300-mg ibuprofen solution for infusion | Postoperative pain | Hyloris Pharmaceuticals SA, of Liege, Belgium | NDA | Standard | 10/17/2023 |
Omvoh (mirikizumab-mrkz) | Humanized IgG4 monoclonal antibody that binds to the p19 subunit of interleukin 23 | Ulcerative colitis | Eli Lilly and Co., of Indianapolis | BLA | N/A | 10/27/2023 |
Opdivo (nivolumab) | PD-1 immune checkpoint inhibitor | Resected stage IIB or IIC melanoma | Bristol Myers Squibb Co., of New York | sBLA | N/A | 10/13/2023 |
Penbraya (meningococcal groups A, B, C, W and Y vaccine), | Pentavalent meningococcal vaccine | Meningococcal disease | Pfizer Inc., of New York | BLA | N/A | 10/20/2023 |
Qlosi (pilocarpine hydrochloride ophthalmic solution) | Stimulates cholinergic receptors | Presbyopia | Orasis Pharmaceuticals, of Ponte Verda, Fla. | NDA | Standard | 10/17/2023 |
Rozlytrek (entrectinib) | Tyrosine kinase inhibitor | Solid tumors (pediatric patients older than 1 month) | Genentech Inc., of South San Francisco, a unit of Roche Holding AG | sNDA | Accelerated | 10/20/2023 |
Rozlytrek (entrectinib) | Tyrosine kinase inhibitor | Solid tumors (pellet formulation) | Genentech Inc., of South San Francisco, a unit of Roche Holding AG | NDA | Priority;Orphan | 10/20/2023 |
Tibsovo (ivosidenib) | Oral L-prolinamide-derived inhibitor of isocitrate dehydrogenase 1 | IDH1-mutated relapsed or refractory myelodysplastic syndromes | Servier Pharmaceuticals LLC, of Paris and Boston | sNDA | N/A | 10/24/2023 |
Vabysmo (faricimab) | Bispecific antibody for the eye targeting Ang-2 and VEGF-A | Macular edema following retinal vein occlusion | Genentech Inc., a subsidiary of Roche Holding AG, of Basel, Switzerland | sBLA | N/A | 10/26/2023 |
Velsipity (etrasimod) | Sphingosine-1 phosphate receptor-1 agonist | Ulcerative colitis | Pfizer Inc., of New York | NDA | NME;standard | 10/12/2023 |
Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules) | Vonoprazan, a potassium-competitive acid blocker; acid suppressant | Helicobacter pylori infection | Phathom Pharmaceuticals Inc., of Florham Park, N.J. | sNDA | N/A | 10/30/2023 |
Voxzogo (vosoritide) | C-type natriuretic peptide analogue; positive regulator of the signaling pathway downstream of FGFR3 | Achondroplasia | Biomarin Pharmaceutical Inc., of San Rafael, Calif. | sNDA | N/A | 10/20/2023 |
Wezlana (ustekinumab-auub) | Biosimilar to and interchangeable with Stelara (ustekinumab, Johnson & Johnson) | Multiple inflammatory diseases | Amgen Inc., of Thousand Oaks, Calif. | BLA | N/A | 10/31/2023 |
Xphozah (tenapanor) | Inhibits NHE3 | Control of serum phosphate in adult patients with chronic kidney disease | Ardelyx Inc., of Waltham, Mass. | NDA | Standard | 10/17/2023 |
Zilbrysq (zilucoplan) | C5 complement inhibitor | Generalized myasthenia gravis | UCB SA, of Brussels | NDA | Standard;Orphan; NME | 10/17/2023 |
Zoryve (roflumilast) cream 0.3% | PDE4 inhibitor | Plaque psoriasis | Arcutis Biotherapeutics Inc., of Westlake Village, Calif. | sNDA | N/A | 10/6/2023 |
Zymfentra (infliximab-dyyb) | Subcutaneous version of Celltrion's infliximab biosimilar; blocks TNF-alpha | Moderately to severely active ulcerative colitis and Crohn's disease | Celltrion USA, of Jersey City, N.J. | sBLA | N/A | 10/23/2023 |
Adzynma (apadamtase alfa, TAK-755) | Recombinant ADAMTS13 protein | Congenital thrombotic thrombocytopenic purpura | Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan | BLA | Fast track;Priority;Orphan | 11/9/2023 |
Augtyro (repotrectinib) | Tyrosine kinase inhibitor | Locally advanced or metastatic ROS1-positive non-small-cell lung cancer | Bristol Myers Squibb Co., of New York | NDA | NME; priority; orphan | 11/15/2023 |
Defencath | Antibacterial and antifungal solution | Reduction of catheter-related bloodstream infections | Cormedix Inc., of Berkeley Heights, N.J. | NDA | NME; priority | 11/15/2023 |
Exparel (bupivacaine) | Bupivacaine liposome injectable suspension | Pain after lower extremity surgery | Pacira Biosciences Inc., of Parsippany, N.J. | sNDA | N/A | 11/10/2023 |
Fruzaqla (fruquintinib) | VEGFR-1, -2 and -3 inhibitor | Metastatic colorectal cancer | Hutchmed Ltd., of Hong Kong, and Takeda Pharmaceutical Co. Ltd., of Tokyo | NDA | NME;Priority;fast track | 11/8/2023 |
Ixchiq (single-dose, live-attenuated vaccine) | Single-shot chikungunya vaccine | Chikungunya virus infection | Valneva SE, of Saint Herblain, France | BLA | Accelerated; Breakthrough; Fast track; Priority | 11/9/2023 |
Keytruda (pembrolizumab) | Anti-PD-1 antibody | Locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 11/16/2023 |
Ogsiveo (Nirogacestat) | Oral, selective, small-molecule gamma secreatase inhibitor | Desmoid tumors | Springworks Therapeutics Inc., of Stamford, Conn. | NDA | NME; Priority; orphan | 11/27/2023 |
Truqap (capivasertib) | AKT inhibitor | HR-positive, HER2-low or negative, locally advanced or metastatic breast cancer | Astrazeneca plc, of Cambridge, U.K. | NDA | NME; priority | 11/16/2023 |
Voquenza (vonoprazan) tablets 10 mg and 20 mg | Vonoprazan tablets; potassium-competitive acid blocker | Erosive esophagitis | Phathom Pharmaceuticals Inc., of Florham Park, N.J. | NDA | Standard | 11/1/2023 |
Xtandi (enzalutamide) | Androgen receptor signaling inhibitor | Non-metastatic castration-sensitive prostate cancer | Pfizer Inc., of New York | sNDA | Priority; Fast Track | 11/20/2023 |
Zepbound (tirzepatide) | Peptide co-agonist of gastric inhibitory polypeptide and GLP-1 | Obesity or overweight | Eli Lilly and Co., of Indianapolis | NDA | Priority; fast track | 11/8/2023 |
Adbry (tralokinumab-ldrm) | Monoclonal antibody targeting interleukin-13 | Moderate to severe atopic dermatitis | Leo Pharma A/S, of Ballerup, Denmark | sBLA | N/A | 12/14/2023 |
Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), | Immune human globulin intravenous | Primary humoral immunodeficiency | GC Biopharma Corp., of Yongin, South Korea | BLA | N/A | 12/19/2023 |
BAT-1706 | Biosimilar to Avastin (bevacizumab) | Metastatic colorectal cancer, non-squamous non-small-cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma and persistent, recurrent or metastatic cervical cancer; ovarian cancer | Bio-Thera Solutions, of Guangzhou, China | BLA | N/A | 12/7/2023 |
Bivigam | Immune globulin intravenous, human | Primary humoral immunodeficiency | Adma Biologics Inc., of Ramsey, N.J. | sBLA | N/A | 12/12/2023 |
Brukinsa (zanubrutinib) | Small-molecule inhibitor of Bruton's tyrosine kinase | Relapsed or refractory chronic lymphocytic leukemia | Beigene Ltd., of Basel, Switzerland, Beijing, and Cambridge, Mass. | sNDA | N/A | 12/22/2023 |
Casgevy (exagamglogene autotemcel, exa-cel) | An autologous, ex vivo CRISPR/Cas9 gene-edited therapy | Sickle cell disease | Vertex Pharmaceuticals Inc., of Boston, and Crispr Therapeutics, of Zug, Switzerland | BLA | Priority; fast track; orphan; Rare Pediatric Disease; Regenerative Medicine Advanced Therapy | 12/8/2023 |
Fabhalta (iptacopan) | Oral targeted factor B inhibitor of alternative complement pathway | Paroxysmal nocturnal hemoglobinuria | Novartis AG, of Basel, Switzerland | NDA | NME; Priority; orphan | 12/5/2023 |
Filsuvez (Oleogel-S10) | Herbals, dry birch bark extract combined with sunflower oil | Junctional epidermolysis bullosa and dystrophic epidermolysis bullosa | NDA | N/A | 12/19/2023 | |
Idose TR | Sustained-release travoprost implant | Reduction of intraocular pressure in patients with ocular hypertension or open-angle glaucoma | Glaukos Corp., of Aliso Viejo, Calif. | NDA | Standard | 12/13/2023 |
Iwilfin (eflornithine; previously DFMO) | 192-mg tablets; irreversible inhibitor of ornithine decarboxylase | High-risk neuroblastoma | U.S. Worldmeds LLC., of Louisville, Ky. | NDA | Priority; Orphan | 12/13/2023 |
Jaypirca (pirtobrutinib; LOXO-305) | Selective BTK inhibitor | Chronic lymphocytic leukemia or small lymphocytic lymphoma | Loxo Oncology at Lilly, a unit of Indianapolis-based Eli Lilly and Co. | sNDA | Accelerated | 12/1/2023 |
Keytruda (pembrolizumab) | Monoclonal antibody targeting PD-1 | Locally advanced or metastatic urothelial cancer | Merck & Co. Inc., of Rahway, N.J. | sBLA | N/A | 12/19/2023 |
Lyfgenia (lovotibeglogene autotemcel, lovo-cel) | HBB gene stimulator | Sickle cell disease | Bluebird Bio Inc., of Sommerville, Mass. | BLA | Priority | 12/8/2023 |
Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet | ATP citrate lyase inhibitor | Primary hyperlipidemia | Esperion Therapeutics Inc., of Ann Arbor, Mich. | sNDA | N/A | 12/13/2023 |
Tarpeyo (budesonide) | Glucocorticoid receptor agonist; delayed release capsules | Primary immunoglobulin A nephropathy | Calliditas Therapeutics AB, of Stockholm | sNDA | Priority | 12/20/2023 |
Tarpeyo (budesonide) | Delayed release capsules | Primary immunoglobulin A nephropathy | Calliditas Therapeutics AB, of Stockholm | sNDA | N/A | 12/20/2023 |
Trogarzo (ibalizumab-uiyk) | Long-acting, CD4-directed, post-attachment HIV-1 inhibitor | HIV-1 infection | Theratechnologies Inc., of Montreal | sBLA | Prior approval supplement | 12/13/2023 |
Udenyca Onbody (pegfilgrastim) | Pegfilgrastim biosimilar administered via on-body injector | Febrile neutropenia | Coherus Biosciences Inc., of Redwood City, Calif. | BLA | N/A | 12/26/2023 |
Wainua (eplontersen) | Ligand-conjugated antisense medicine | Hereditary transthyretin-mediated amyloid polyneuropathy | Ionis Pharmaceuticals Inc., of Carlsbad, Calif. | NDA | NME;Priority | 12/21/2023 |
Welireg | Oral hypoxia-inducible factor-2 alpha inhibitor | Advanced renal cell carcinoma | Merck & Co. Inc., of Rahway, N.J. | sNDA | N/A | 12/14/2023 |
Zoryve (roflumilast) topical foam | Once-daily topical foam formulation of selective PDE4 inhibitor | Seborrheic dermatitis | Arcutis Biotherapeutics Inc., of Westlake Village, Calif. | NDA | standard | 12/15/2023 |