FDA Drug Approvals

Approval Date Drug Name Company Application ID Active Ingredients FDA-approved use on approval date Submission Classification Review Priority Drugs@FDA Link
2025-08-01 E-Z-Disk Bracco NDA #219840 Barium Sulfate Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219840
2025-08-08 Hernexeos Boehringer Ingelheim Pharmaceuticals Inc NDA #219042 Zongertinib To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219042
2025-08-08 Kyxata Avyxa Holdings NDA #219921 Carboplatin Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219921
2025-08-12 Brinsupri Insmed Inc NDA #217673 Brensocatib To treat non-cystic fibrosis bronchiectasis Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217673
2025-08-15 Cyklx American Genomics LLC NDA #218643 Articaine Type 3 - New Dosage Form and Type 4 - New Combination Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218643
2025-08-15 Tonmya Tonix Pharmaceuticals Inc NDA #219428 Cyclobenzprine Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219428
2025-07-03 Ekterly Kalvista NDA #219301 Sebetralstat To treat acute attacks of hereditary angioedema Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219301
2025-07-15 Kirsty Biocon Biologics Inc BLA #761188 Insulin Aspart-XJHZ https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761188
2025-07-16 Famotidine Sagent NDA #219935 Famotidine Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219935
2025-07-23 Anzupgo Leo Pharma AS NDA #219155 Delgocitinib To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219155
2025-07-23 Vostally Rosemont Pharms NDA #219757 Ramipril Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219757
2025-07-24 Sdamlo Brillian Pharma NDA #219531 Amlodipine Besylate Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219531
2025-07-24 Doptelet Sprinkle Akarx Inc NDA #219696 Avatrombopag Maleate Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219696
2025-07-28 Sephience PTC Therap NDA #219666 Sepiapterin To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219666
2025-07-29 Vyscoxa Codadose Inc NDA #211759 Celecoxib Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211759
2025-07-30 Atmeksi Rosemont Pharms NDA #219843 Methocarbamol Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219843
2025-07-31 VIZZ LENZ Therap NDA #218585 Aceclidine Hydrochloride Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218585
2025-07-31 Alhemo Novo Nordisk Inc BLA #761428 Concizumab https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761428
2025-06-05 Xifyrm Azurity NDA #218395 Meloxicam Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218395
2025-06-05 Widaplik George Medicines NDA #219423 Amlodipine Besylate; Indapamide; Telmisartan Type 4 - New Combination Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219423
2025-06-09 Rocuronium Bromide Fresenius Kabi USA NDA #217472 Rocuronium Bromide Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217472
2025-06-09 Enflonsia Merck Sharp Dohme BLA #761432 Clesrovimab-cfor To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season Drug Trials Snapshot https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761432
2025-06-10 Brukinsa Beone Medicines USA NDA #218785 Zanubrutinib Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218785
2025-06-11 Ibtrozi Nuvation NDA #219713 Taletrectinib Adipate Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219713
2025-06-12 Zusduri Urogen Pharma NDA #215793 Mitomycin Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215793
2025-06-16 Arynta Azurity NDA #219847 Lisdexamfetamine Dimesylate Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219847
2025-06-16 Carbon Dioxide, USP General Distributing Company NDA #220634 Carbon Dioxide Unknown https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220634
2025-06-16 Andembry CSL Behring LLC BLA #761367 Garadacimab-gxii To prevent attacks of hereditary angioedema https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761367
2025-06-18 Yeztugo Gilead Sciences Inc NDA #220018 Lenacapavir Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220018
2025-06-18 Yeztugo Gilead Sciences Inc NDA #220018 Lenacapavir Sodium Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220018
2025-06-18 Yeztugo Gilead Sciences Inc NDA #220020 Lenacapavir Sodium Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220020
2025-06-23 Datroway Daiichi Sankyo Inc BLA #761464 Datopotamab Deruxtecan-dlnk To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic diseaseDrug Trials Snapshot https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761464
2025-06-27 Avgemsi Avyxa Holdings NDA #219920 Gemcitabine Hydrochloride Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219920
2025-05-08 Avmapki Fakzynja Co-pack (copackaged) Verastem Inc NDA #219616 Avutometinib Potassium; Defactinib Hydrochloride Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219616
2025-05-14 Brekiya (autoinjector) Amneal NDA #215400 Dihydroergotamine Mesylate Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215400
2025-05-14 Emrelis Abbvie Inc BLA #761384 Telisotuzumab Vedotin-tllv To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy Drug Trials Snapshot https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761384
2025-05-20 Aususvar Auson Pharm NDA #217062 Rivaroxaban Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217062
2025-05-22 Starjemza Bio-thera Solutions LTD BLA #761419 Ustekinumab-hmny https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761419
2025-05-23 Yutrepia Liquidia Tech NDA #213005 Treprostinil Sodium Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213005
2025-05-28 Tryptyr Alcon Labs Inc NDA #217370 Acoltremon To treat the signs and symptoms of dry eye diseaseDrug Trials Snapshot Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217370
2025-05-28 Khindivi ETON NDA #218980 Hydrocortisone Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218980
2025-05-30 Phenylephrine Hydrochloride IN 0.9% Sodium Chloride Dr Reddys Labs SA NDA #216830 Phenylephrine Hydrochloride Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216830
2025-04-02 Libervant Aquestive NDA #218623 Diazepam Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218623
2025-04-02 Vanrafia Novartis NDA #219208 Atrasentan Hydrochloride Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219208
2025-04-03 Piperacillin AND Tazobactam AND Sodium Chloride IN Duplex Container B Braun Medical NDA #206056 Piperacillin Sodium; Tazobactam Sodium Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206056
2025-04-09 Trabectedin Ever Valinject NDA #219617 Trabectedin Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219617
2025-04-09 Jobevne Biocon Biologics Inc BLA #761175 Bevacizumab-NWGD https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761175
2025-04-10 Lopressor Rubicon Research NDA #219373 Metoprolol Tartrate Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219373
2025-04-10 Livmarli Mirum NDA #219485 Maralixibat Chloride Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219485
2025-04-15 Mezofy CMG Pharm Co Ltd NDA #211448 Aripiprazole Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211448
2025-04-17 Eliquis Bristol NDA #220073 Apixaban Type 3 - New Dosage Form Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220073
2025-04-17 Eliquis Sprinkle Bristol NDA #220073 Apixaban Type 3 - New Dosage Form Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220073
2025-04-21 Carbon Dioxide, USP Mitchell Wedling Supply NDA #220461 Carbon Dioxide https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220461
2025-04-22 Qamzova Nanjing Delova NDA #217593 Meloxicam Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217593
2025-04-23 Penpulimab-KCQX Akeso Biopharma BLA #761258 Penpulimab-KCQX In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapyDrug Trials Snapshot https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761258
2025-04-29 Imaavy Janssen Biotech BLA #761430 Nipocalimab-AAHU To treat generalized myasthenia gravisDrug Trials Snapshot https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761430
2025-04-30 Atzumi Satsuma Pharms NDA #217901 Dihydroergotamine Mesylate Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217901
2025-03-03 Tevimbra Beigene BLA #761380 Islelizumab-jsgr https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761380
2025-03-07 Omlyclo Celltrion Inc BLA #761399 Omalizumab-IGEC https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761399
2025-03-13 Epinephrine Fresenius Kabi USA NDA #215425 Epinephrine Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215425
2025-03-13 Arbli Scienture NDA #218772 Losartan Potassium Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218772
2025-03-14 Tyenne Fresenius Kabi USA BLA #761449 Tocilizumab-AAZG https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761449
2025-03-17 Hemiclor PRM Pharma NDA #218647 Chlorthalidone Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218647
2025-03-20 Gozellix Telix Innovations NDA #219592 Gallium Ga-68 Gozetotide Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219592
2025-03-25 Blujepa Glaxosmithkline NDA #218230 Gepotidacin Mesylate Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218230
2025-03-25 Bomyntra Fresenius Kabi USA LLC BLA #761398 Denosumab-bnht https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761398
2025-03-25 Conexxence Fresenius Kabi USA LLC BLA #761398 Denosumab-bnht https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761398
2025-03-25 Denosumab-bnht Fresenius Kabi USA LLC BLA #761398 Denosumab-bnht https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761398
2025-03-26 Vykat XR Soleno Therap NDA #216665 Diazoxide Choline Type 2 - New Active Ingredient Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216665
2025-03-28 Qfitlia Genzyme Corp NDA #219019 Fitusiran Sodium Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219019
2025-02-02 Carbon Dioxide, USP Welders Supply Company of Louisville Inc NDA #220266 Carbon Dioxide Medical Gas https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220266
2025-02-03 Onapgo MDD US NDA #214056 Apomorphine Hydrochloride Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214056
2025-02-07 Emblaveo Abbvie NDA #217906 Avibactam Sodium; Aztreonam Type 4 - New Combination Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217906
2025-02-11 Evrysdi Genentech Inc NDA #219285 Risdiplam Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219285
2025-02-11 Gomekli Springworks NDA #219379 Mirdametinib To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection Drug Trials Snapshot Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219379
2025-02-11 Gomekli Springworks NDA #219389 Mirdametinib To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection Drug Trials Snapshot Type 3 - New Dosage Form Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219389
2025-02-13 Denosumab-dssb Samsung Bioepis Co Ltd BLA #761392 Denosumab-dssb https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761392
2025-02-13 Ospomyv Samsung Bioepis Co Ltd BLA #761392 Denosumab-dssb https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761392
2025-02-13 Xbryk Samsung Bioepis Co Ltd BLA #761392 Denosumab-dssb https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761392
2025-02-14 Romvimza Deciphera Pharms NDA #219304 Vimseltinib To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidityDrug Trials Snapshot Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219304
2025-02-14 Merilog Sanofi-Aventis US LLC BLA #761325 Insulin Aspart-szjj https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761325
2025-02-14 Merilog Solostar Sanofi-Aventis US LLC BLA #761325 Insulin Aspart-szjj https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761325
2025-02-19 Nilotinib D-Tartrate Cipla NDA #218922 Nilotinib D-tartrate Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218922
2025-02-21 Diltiazem Hydrochloride in 0.72% Sodium Chloride HQ SPCLT Pharma NDA #218038 Diltiazem Hydrochloride Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218038
2025-02-21 Ctexli Mirum NDA #219488 Chenodiol Type 5 - New Formulation or New Manufacturer Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219488
2025-02-24 Miudella Sebela Womens HLTH NDA #218201 Copper Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218201
2025-02-28 Epinephrine Bitartrate in 0.9% Sodium Chloride Baxter Hlthcare Corp NDA #218475 Epinephrine Bitartrate Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218475
2025-02-28 Osenvelt Celltrion Inc BLA #761404 Denosumab-bmwo https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761404
2025-02-28 Stoboclo Celltrion Inc BLA #761404 Denosumab-bmwo https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761404
2025-01-16 Brynovin Azurity NDA #219122 Sitagliptin Hydrochloride Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219122
2025-01-17 Myinfla Columbia Therapeutics Inc NDA #216469 Colchicine Type 5 - New Formulation or New Manufacturer Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216469
2025-01-17 Datroway Daiichi Sankyo Inc BLA #761394 Datopotamab Deruxtecan-dlnk To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic diseaseDrug Trials Snapshot https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761394
2025-01-21 Grafapex Medexus NDA #214759 Treosulfan For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndromeDrug Trials Snapshot Type 1 - New Molecular Entity Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214759
2025-01-24 Avtozma Celltrion Inc BLA #761420 Tocilizumab-anoh https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761420
2025-01-28 Inzirqo Novitium Pharma NDA #219141 Hydrochlorothiazide Type 3 - New Dosage Form Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219141
2025-01-30 Symbravo Axsome NDA #215431 Meloxicam; Rizatriptan Benzoate Type 4 - New Combination Standard https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215431
2025-01-30 Journavx Vertex Pharms Inc NDA #219209 Suzetrigine To treat moderate to severe acute painPress Release Drug Trials Snapshot Type 1 - New Molecular Entity Priority https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219209