FDA Drug Approvals

Updated through September 3, 2026
Approval Date Drug Name Company Application ID Active Ingredients FDA-approved use on approval date Submission Classification Review Priority FDA Source
2026-09-03 Zanvastro Ionis Pharmaceuticals, Inc. NDA / see FDA record Zilganersen To treat Alexander disease in pediatric and adult patients NDA - Novel Drug Priority FDA source
2026-08-28 Mimrylo Takeda Development Center Americas, Inc. NDA / see FDA record Rusfertide To treat erythrocytosis in adults with polycythemia vera NDA - Novel Drug Priority FDA source
2026-08-27 Lisraya Priovant Therapeutics, Inc. NDA #220106 Brepocitinib To treat dermatomyositis in adults NDA - Novel Drug Priority FDA source
2026-08-26 Rasonque Revolution Medicines, Inc. NDA / see FDA record Daraxonrasib To treat adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy NDA - Novel Drug Priority FDA source
2026-08-19 Pasatru See FDA record BLA #761508 Garetosmab-grts To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva BLA - Original Priority FDA source
2026-08-14 Sodium Bicarbonate See FDA record NDA #218524 Sodium bicarbonate See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-08-13 Tauklarify Lantheus Holdings, Inc. NDA #220496 Florquinitau F 18 See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-08-13 Zenbexus Bristol Myers Squibb NDA #221075 Iberdomide To be used in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent Type 1 - New Molecular Entity Priority FDA source
2026-08-05 Orzeyful Takeda Pharmaceuticals NDA #220860 Oveporexton See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-07-31 Zimrixby See FDA record BLA #761376 See FDA record See FDA record BLA - Original Priority FDA source
2026-07-29 Glycophos See FDA record NDA #220381 See FDA record See FDA record Type 2 - New Active Ingredient Standard FDA source
2026-07-29 Qlonilik See FDA record NDA #221094 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-07-28 Gwyn Lo See FDA record NDA #219990 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-07-24 Garzulys See FDA record BLA #761497 See FDA record See FDA record BLA - Original Priority FDA source
2026-07-24 Lytenava Outlook Therapeutics BLA #761320 Bevacizumab-vikg See FDA record Type 1 + Type 4 Priority FDA source
2026-07-24 Simtriyo See FDA record NDA #218145 Centanafadine See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-07-24 Tylenol with Naproxen See FDA record NDA #219962 Acetaminophen and naproxen See FDA record Type 4 - New Combination Standard FDA source
2026-07-22 Jideytro See FDA record NDA #220185 Zidesamtinib See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-07-19 Air See FDA record NDA #221805 See FDA record See FDA record See FDA record Standard FDA source
2026-07-15 Lipfendra See FDA record NDA #220848 Enlicitide decanoate See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-07-14 Revtorpyk See FDA record NDA #219908 Gedatolisib See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-07-10 Zyogreen See FDA record NDA #218579 See FDA record See FDA record Type 3 - New Dosage Form Standard FDA source
2026-07-09 Sarclisa Escena Sanofi BLA #761445 See FDA record See FDA record Type 3 - New Dosage Form Standard FDA source
2026-07-09 Sodium Bicarbonate See FDA record NDA #220790 Sodium bicarbonate See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-07-07 Trutakna See FDA record BLA #761486 Atacicept-vymj See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-06-26 Lumvoa See FDA record BLA #761530 Veligrotug-vvze See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-06-24 Navitrux See FDA record NDA #220436 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-06-17 Utebzi See FDA record NDA #215960 Tebipenem pivoxil See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-06-16 Aprepitant See FDA record NDA #218754 Aprepitant See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-06-12 Ambelvist See FDA record NDA #219627 Gadoquatrane See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-06-02 Ranluspec See FDA record BLA #761480 See FDA record See FDA record Type 2 - New Active Ingredient Standard FDA source
2026-06-02 Tiocystin See FDA record NDA #212927 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-05-29 Cavhanza See FDA record NDA #217379 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-05-29 Cipepofol See FDA record NDA #220482 Cipepofol See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-05-29 Xocova See FDA record NDA #220442 Ensitrelvir See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-05-29 Zaynich See FDA record NDA #220787 Cefepime and zidebactam See FDA record Type 1 + Type 4 Priority FDA source
2026-05-27 Decnupaz See FDA record BLA #761460 Pivekimab sunirine-pvzy See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-05-22 Differin Epiduo Acne Gel See FDA record NDA #220736 Adapalene and benzoyl peroxide Acne treatment; partial prescription-to-OTC switch Type 8 - Partial Rx-to-OTC Standard FDA source
2026-05-22 Hepcludex See FDA record BLA #761468 Bulevirtide-gmod See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-05-15 Baxfendy See FDA record NDA #219878 Baxdrostat See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-05-15 Immgolis See FDA record BLA #761452 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-05-14 Trimbow See FDA record NDA #219622 See FDA record See FDA record Type 4 - New Combination Standard FDA source
2026-05-13 Beqalzi See FDA record NDA #220711 Sonrotoclax See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-05-07 Ennumo See FDA record BLA #761147 See FDA record See FDA record BLA - Original Priority FDA source
2026-05-01 Evdi See FDA record NDA #220837 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-05-01 Jakafi XR See FDA record NDA #217180 Ruxolitinib See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-05-01 Veppanu See FDA record NDA #219835 Vepdegestrant See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-04-29 Langlara See FDA record BLA #761412 See FDA record See FDA record BLA - Original Standard FDA source
2026-04-24 Saphnelo AstraZeneca BLA #761451 Anifrolumab-fnia See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-04-20 Idvynso See FDA record NDA #216964 Doravirine and islatravir See FDA record Type 1 + Type 4 Standard FDA source
2026-04-01 Foundayo Eli Lilly and Company NDA #220934 Orforglipron See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-03-30 Epinephrine See FDA record NDA #220626 Epinephrine See FDA record New Combination and New Formulation or New Manufacturer Standard FDA source
2026-03-27 Ponlimsi See FDA record BLA #761385 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-03-26 Awiqli FlexTouch Novo Nordisk BLA #761326 Insulin icodec-abae See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-03-25 Lifyorli (copackaged) Corcept Therapeutics NDA #220641 Relacorilant See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-03-24 Avlayah Ultragenyx Pharmaceutical Inc. BLA #761485 Tividenofusp alfa-eknm See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-03-20 Atoncy See FDA record NDA #220320 See FDA record See FDA record Type 3 - New Dosage Form Standard FDA source
2026-03-19 Flavalta See FDA record NDA #216564 See FDA record See FDA record Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-03-17 Icotyde Johnson & Johnson / Janssen NDA #220149 Icotrokinra See FDA record Type 1 - New Molecular Entity Priority FDA source
2026-03-17 Lynavoy Ipsen Biopharmaceuticals, Inc. NDA #220295 Linerixibat See FDA record Type 1 - New Molecular Entity Standard FDA source
2026-03-06 PYLARIFY TruVu Lantheus Holdings Inc. NDA (new formulation) Piflufolastat F 18 New formulation of F18 PSMA-targeted PET imaging agent for recurrent and/or metastatic prostate cancer Type 5 - New Formulation or New Manufacturer Standard FDA source
2026-03-06 Sotyktu (new indication) Bristol Myers Squibb NDA #215416/S Deucravacitinib To treat adults with active psoriatic arthritis (new indication; previously approved for plaque psoriasis) Supplemental NDA - New Indication Standard FDA source
2026-02-27 Yuviwel Ascendis Pharma A/S BLA #761562 Navepegritide To treat achondroplasia in children aged 2 years and older (accelerated approval) Biologics License (Original) Priority FDA source
2026-02-26 Dupixent (new indication) Sanofi / Regeneron BLA #761055/S Dupilumab To treat adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) — first drug approved for this condition Supplemental BLA - New Indication Standard FDA source
2026-02-25 Desmoda Eton Pharmaceuticals, Inc. NDA #ET-600 Desmopressin Acetate To manage central diabetes insipidus (arginine vasopressin deficiency) — oral solution formulation Type 3 - New Dosage Form Standard FDA source
2026-02-23 Loargys Immedica Pharma AB BLA #761xxx Pegzilarginase-nbln To treat hyperargininemia in patients with Arginase 1 Deficiency (accelerated approval) Biologics License (Original) Priority FDA source
2026-02-20 Bysanti Vanda Pharmaceuticals Inc. NDA #215xxx Milsaperidone To treat schizophrenia and acute bipolar I disorder in adults Type 1 - New Molecular Entity Standard FDA source
2026-02-13 Adquey Acrotech Biopharma Inc. NDA #216xxx Difamilast 1% To treat mild-to-moderate atopic dermatitis Type 1 - New Molecular Entity Standard FDA source
2026-02-08 Hernexeos (expanded indication) Boehringer Ingelheim Pharmaceuticals Inc. NDA #219042/S Zongertinib Expanded to include treatment-naive adults with unresectable or metastatic non-squamous NSCLC with HER2 TKD activating mutations (previously limited to post-prior-therapy patients) Supplemental NDA - New Indication (National Priority Voucher) Priority FDA source
2026-01-28 Yuvezzi Tenpoint Therapeutics, Ltd. NDA #218xxx Brimonidine Tartrate and Carbachol To treat presbyopia in adults — first combination alpha-adrenergic/cholinergic agonist eye drop for this indication Type 4 - New Combination Standard FDA source
2026-01-12 Zycubo Sentynl Therapeutics, Inc. NDA #216xxx Copper Histidinate To treat Menkes disease in pediatric patients — copper replacement therapy Type 1 - New Molecular Entity Priority FDA source
2025-12-30 Nereus Vanda Pharmaceuticals Inc. NDA #217xxx Tradipitant To treat vomiting associated with motion sickness in adults Type 1 - New Molecular Entity Standard FDA source
2025-12-23 Yartemlea Omeros Corporation BLA #761xxx Narsoplimab-wuug To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) in adults and pediatric patients aged 2 years and older Biologics License (Original) Priority FDA source
2025-12-19 Myqorzo Cytokinetics, Inc. NDA #219083 Aficamten To treat symptomatic obstructive hypertrophic cardiomyopathy in adults Type 1 - New Molecular Entity Priority FDA source
2025-12-16 Exdensur GSK (GlaxoSmithKline) BLA #761xxx Depemokimab-ulaa To treat severe asthma with an eosinophilic phenotype as an add-on maintenance therapy Biologics License (Original) Priority FDA source
2025-12-12 Cardamyst Milestone Pharmaceuticals Inc. NDA #218571 Etripamil To treat episodes of paroxysmal supraventricular tachycardia in adults — calcium channel blocker nasal spray Type 1 - New Molecular Entity Standard FDA source
2025-12-12 Lerochol LIB Therapeutics LLC NDA #217xxx Lerodalcibep-liga To reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as adjunct to diet and exercise Type 1 - New Molecular Entity Standard FDA source
2025-12-12 Nuzolvence Innoviva Specialty Therapeutics NDA #217xxx Zoliflodacin To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and adolescents aged 12 and older Type 1 - New Molecular Entity Priority FDA source
2025-11-25 Voyxact Chinook Therapeutics (Novartis) BLA #761434 Sibeprenlimab-szsi To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression Biologics License (Original) Priority FDA source
2025-11-19 Hyrnuo Bayer Healthcare Pharms NDA #219972 Sevabertinib Kinase inhibitor to treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy Type 1 - New Molecular Entity Priority FDA source
2025-11-18 Redemplo Arrowhead Pharmaceuticals, Inc. NDA #219947 Plozasiran To reduce triglycerides in adults with familial chylomicronemia syndrome Type 1 - New Molecular Entity Standard FDA source
2025-11-13 Komzifti Kura Oncology, Inc. NDA #220305 Ziftomenib To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options Type 1 - New Molecular Entity Priority FDA source
2025-11-13 Poherdy Shanghai Henlius Biotech, Inc. BLA #761450 Pertuzumab-dpzb Use in combination with trastuzumab and docetaxel/chemotherapy for the treatment of adults with HER2-positive breast cancer FDA source
2025-11-03 Kygevvi UCB Inc NDA #219792 Doxecitine and Doxribtimine To treat thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years Type 1 - New Molecular Entity Priority FDA source
2025-10-24 Lynkuet Bayer HealthCare Pharmaceuticals Inc. NDA #219469 Elinzanetant To treat moderate to severe vasomotor symptoms due to menopause Type 1 - New Molecular Entity Standard FDA source
2025-10-24 RESNIBEN Azurity Pharmaceuticals, Inc. NDA #220258 Cabozantinib Standard FDA source
2025-10-24 Rocuronium Bromide Sterinova Inc. NDA #219108 Rocuronium Bromide Adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation FDA source
2025-10-23 Blenrep GlaxoSmithKline LLC BLA #761440 Belantamab Mafodotin-blmf Treatment of adult patients with relapsed or refractory multiple myeloma FDA source
2025-10-23 Dehydrated Alcohol Royal Pharmaceuticals, LLC. NDA #214988 Alcohol Type 5 - New Formulation or New Manufacturer Priority FDA source
2025-10-23 Javadin Azurity NDA #220256 Clonidine Hydrochloride Type 3 - New Dosage Form Standard FDA source
2025-10-22 Contepo Meitheal Pharmaceuticals Inc. NDA #212271 Fosfomycin Treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) Type 2 - New Active Ingredient Priority FDA source
2025-10-17 Epioxa HD / Epioxa Kit Glaukos Corporation NDA #219910 Riboflavin 5'-Phosphate Treatment of keratoconus in adults and pediatric patients aged 13 years and older Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-10-16 Ferabright Covis Pharma US NDA #219868 Ferumoxytol Use for MRI of the brain in adults with known or suspected malignant neoplasms to visualize lesions with a disrupted blood-brain barrier Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Standard FDA source
2025-10-07 Jascayd Boehringer Ingelheim NDA #218764 Nerandomilast Treatment of idiopathic pulmonary fibrosis in adult patients Type 1 - New Molecular Entity Priority FDA source
2025-10-02 Eydenzelt Celltrion Inc BLA #761377 Aflibercept-boav FDA source
2025-09-30 Rhapsido Novartis Pharmaceuticals Corporation NDA #218436 Remibrutinib To treat adults with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment Type 1 - New Molecular Entity Standard FDA source
2025-09-25 Inluriyo Eli Lilly and Company NDA #218881 Imlunestrant To treat adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one prior line of endocrine therapy Type 1 - New Molecular Entity Priority FDA source
2025-09-25 Palsonify Crinetics Pharmaceuticals, Inc. NDA #219070 Paltusotine To treat adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option Type 1 - New Molecular Entity Standard FDA source
2025-09-19 Forzinity Stealth BioTherapeutics Inc. NDA #215244 Elamipretide To improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg (accelerated approval) Type 1 - New Molecular Entity Priority FDA source
2025-09-19 Keytruda Qlex Merck Sharp & Dohme LLC BLA #761467 Pembrolizumab and Berahyaluronidase Alfa-pmph Subcutaneous co-formulation for treatment of certain cancers per label Biologics License (Original) Priority FDA source
2025-08-29 Wayrilz Genzyme Corporation (Sanofi) NDA #219685 Rilzabrutinib To treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy Type 1 - New Molecular Entity Priority FDA source
2025-08-15 Cyklx American Genomics LLC NDA #218643 Articaine Type 3 - New Dosage Form and Type 4 - New Combination Standard FDA source
2025-08-15 Tonmya Tonix Pharmaceuticals Inc NDA #219428 Cyclobenzaprine Type 3 - New Dosage Form Standard FDA source
2025-08-12 Brinsupri Insmed Inc NDA #217673 Brensocatib To treat non-cystic fibrosis bronchiectasis Type 1 - New Molecular Entity Priority FDA source
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 FDA source
2025-08-08 Kyxata Avyxa Holdings NDA #219921 Carboplatin Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-08-01 E-Z-Disk Bracco NDA #219840 Barium Sulfate Standard FDA source
2025-07-31 Alhemo Novo Nordisk Inc BLA #761428 Concizumab FDA source
2025-07-31 VIZZ LENZ Therap NDA #218585 Aceclidine Hydrochloride Type 1 - New Molecular Entity Standard FDA source
2025-07-30 Atmeksi Rosemont Pharms NDA #219843 Methocarbamol Standard FDA source
2025-07-29 Vyscoxa Codadose Inc NDA #211759 Celecoxib Type 3 - New Dosage Form Standard FDA source
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 FDA source
2025-07-24 Doptelet Sprinkle Akarx Inc NDA #219696 Avatrombopag Maleate Type 3 - New Dosage Form Standard FDA source
2025-07-24 Sdamlo Brillian Pharma NDA #219531 Amlodipine Besylate Type 3 - New Dosage Form Standard FDA source
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 FDA source
2025-07-23 Vostally Rosemont Pharms NDA #219757 Ramipril Type 3 - New Dosage Form Standard FDA source
2025-07-16 Famotidine Sagent NDA #219935 Famotidine Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-07-15 Kirsty Biocon Biologics Inc BLA #761188 Insulin Aspart-XJHZ FDA source
2025-07-03 Ekterly Kalvista NDA #219301 Sebetralstat To treat acute attacks of hereditary angioedema Type 1 - New Molecular Entity Standard FDA source
2025-06-27 Avgemsi Avyxa Holdings NDA #219920 Gemcitabine Hydrochloride Type 5 - New Formulation or New Manufacturer Standard FDA source
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 disease FDA source
2025-06-18 Yeztugo Gilead Sciences Inc NDA #220020 Lenacapavir Sodium Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Priority FDA source
2025-06-18 Yeztugo Gilead Sciences Inc NDA #220018 Lenacapavir Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated Priority FDA source
2025-06-16 Andembry CSL Behring LLC BLA #761367 Garadacimab-gxii To prevent attacks of hereditary angioedema FDA source
2025-06-16 Arynta Azurity NDA #219847 Lisdexamfetamine Dimesylate Type 3 - New Dosage Form Standard FDA source
2025-06-16 Carbon Dioxide, USP General Distributing Company NDA #220634 Carbon Dioxide Unknown FDA source
2025-06-12 Zusduri Urogen Pharma NDA #215793 Mitomycin Type 3 - New Dosage Form Standard FDA source
2025-06-11 Ibtrozi Nuvation NDA #219713 Taletrectinib Adipate Type 1 - New Molecular Entity Priority FDA source
2025-06-10 Brukinsa Beone Medicines USA NDA #218785 Zanubrutinib Type 3 - New Dosage Form Standard FDA source
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 FDA source
2025-06-09 Rocuronium Bromide Fresenius Kabi USA NDA #217472 Rocuronium Bromide Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-06-05 Widaplik George Medicines NDA #219423 Amlodipine Besylate; Indapamide; Telmisartan Type 4 - New Combination Standard FDA source
2025-06-05 Xifyrm Azurity NDA #218395 Meloxicam Standard FDA source
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 FDA source
2025-05-28 Khindivi ETON NDA #218980 Hydrocortisone Type 3 - New Dosage Form Standard FDA source
2025-05-28 Tryptyr Alcon Labs Inc NDA #217370 Acoltremon To treat the signs and symptoms of dry eye disease Type 1 - New Molecular Entity Standard FDA source
2025-05-23 Yutrepia Liquidia Tech NDA #213005 Treprostinil Sodium Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-05-22 Starjemza Bio-thera Solutions LTD BLA #761419 Ustekinumab-hmny FDA source
2025-05-20 Aususvar Auson Pharm NDA #217062 Rivaroxaban Type 3 - New Dosage Form Standard FDA source
2025-05-14 Brekiya (autoinjector) Amneal NDA #215400 Dihydroergotamine Mesylate Type 5 - New Formulation or New Manufacturer Standard FDA source
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 FDA source
2025-05-08 Avmapki Fakzynja Co-pack (copackaged) Verastem Inc NDA #219616 Avutometinib Potassium; Defactinib Hydrochloride Type 1 - New Molecular Entity Priority FDA source
2025-04-30 Atzumi Satsuma Pharms NDA #217901 Dihydroergotamine Mesylate Type 3 - New Dosage Form Standard FDA source
2025-04-29 Imaavy Janssen Biotech BLA #761430 Nipocalimab-AAHU To treat generalized myasthenia gravis FDA source
2025-04-23 Penpulimab-KCQX Akeso Biopharma BLA #761258 Penpulimab-KCQX In combination with cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent on or after platinum-based chemotherapy FDA source
2025-04-22 Qamzova Nanjing Delova NDA #217593 Meloxicam Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-04-21 Carbon Dioxide, USP Mitchell Wedling Supply NDA #220461 Carbon Dioxide FDA source
2025-04-17 Eliquis Bristol NDA #220073 Apixaban Type 3 - New Dosage Form Priority FDA source
2025-04-17 Eliquis Sprinkle Bristol NDA #220073 Apixaban Type 3 - New Dosage Form Priority FDA source
2025-04-15 Mezofy CMG Pharm Co Ltd NDA #211448 Aripiprazole Type 3 - New Dosage Form Standard FDA source
2025-04-10 Livmarli Mirum NDA #219485 Maralixibat Chloride Type 3 - New Dosage Form Standard FDA source
2025-04-10 Lopressor Rubicon Research NDA #219373 Metoprolol Tartrate Type 3 - New Dosage Form Standard FDA source
2025-04-09 Jobevne Biocon Biologics Inc BLA #761175 Bevacizumab-NWGD FDA source
2025-04-09 Trabectedin Ever Valinject NDA #219617 Trabectedin Type 5 - New Formulation or New Manufacturer Standard FDA source
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 FDA source
2025-04-02 Libervant Aquestive NDA #218623 Diazepam Type 3 - New Dosage Form Standard FDA source
2025-04-02 Vanrafia Novartis NDA #219208 Atrasentan Hydrochloride Type 1 - New Molecular Entity Standard FDA source
2025-03-28 Qfitlia Genzyme Corp NDA #219019 Fitusiran Sodium Type 1 - New Molecular Entity Standard FDA source
2025-03-26 Vykat XR Soleno Therap NDA #216665 Diazoxide Choline Type 2 - New Active Ingredient Priority FDA source
2025-03-25 Blujepa Glaxosmithkline NDA #218230 Gepotidacin Mesylate Type 1 - New Molecular Entity Priority FDA source
2025-03-25 Bomyntra Fresenius Kabi USA LLC BLA #761398 Denosumab-bnht FDA source
2025-03-25 Conexxence Fresenius Kabi USA LLC BLA #761398 Denosumab-bnht FDA source
2025-03-25 Denosumab-bnht Fresenius Kabi USA LLC BLA #761398 Denosumab-bnht FDA source
2025-03-20 Gozellix Telix Innovations NDA #219592 Gallium Ga-68 Gozetotide Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-03-17 Hemiclor PRM Pharma NDA #218647 Chlorthalidone Type 3 - New Dosage Form Standard FDA source
2025-03-14 Tyenne Fresenius Kabi USA BLA #761449 Tocilizumab-AAZG FDA source
2025-03-13 Arbli Scienture NDA #218772 Losartan Potassium Type 3 - New Dosage Form Standard FDA source
2025-03-13 Epinephrine Fresenius Kabi USA NDA #215425 Epinephrine Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-03-07 Omlyclo Celltrion Inc BLA #761399 Omalizumab-IGEC FDA source
2025-03-03 Tevimbra Beigene BLA #761380 Islelizumab-jsgr FDA source
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 FDA source
2025-02-28 Osenvelt Celltrion Inc BLA #761404 Denosumab-bmwo FDA source
2025-02-28 Stoboclo Celltrion Inc BLA #761404 Denosumab-bmwo FDA source
2025-02-24 Miudella Sebela Womens HLTH NDA #218201 Copper Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-02-21 Ctexli Mirum NDA #219488 Chenodiol Type 5 - New Formulation or New Manufacturer Priority FDA source
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 FDA source
2025-02-19 Nilotinib D-Tartrate Cipla NDA #218922 Nilotinib D-tartrate Type 3 - New Dosage Form Standard FDA source
2025-02-14 Merilog Sanofi-Aventis US LLC BLA #761325 Insulin Aspart-szjj FDA source
2025-02-14 Merilog Solostar Sanofi-Aventis US LLC BLA #761325 Insulin Aspart-szjj FDA source
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 morbidity Type 1 - New Molecular Entity Priority FDA source
2025-02-13 Denosumab-dssb Samsung Bioepis Co Ltd BLA #761392 Denosumab-dssb FDA source
2025-02-13 Ospomyv Samsung Bioepis Co Ltd BLA #761392 Denosumab-dssb FDA source
2025-02-13 Xbryk Samsung Bioepis Co Ltd BLA #761392 Denosumab-dssb FDA source
2025-02-11 Evrysdi Genentech Inc NDA #219285 Risdiplam Type 3 - New Dosage Form Standard FDA source
2025-02-11 Gomekli Springworks NDA #219389 Mirdametinib To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection Type 3 - New Dosage Form Priority FDA source
2025-02-11 Gomekli Springworks NDA #219379 Mirdametinib To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection Type 1 - New Molecular Entity Priority FDA source
2025-02-07 Emblaveo Abbvie NDA #217906 Avibactam Sodium; Aztreonam Type 4 - New Combination Priority FDA source
2025-02-03 Onapgo MDD US NDA #214056 Apomorphine Hydrochloride Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-02-02 Carbon Dioxide, USP Welders Supply Company of Louisville Inc NDA #220266 Carbon Dioxide Medical Gas FDA source
2025-01-30 Journavx Vertex Pharms Inc NDA #219209 Suzetrigine To treat moderate to severe acute pain Type 1 - New Molecular Entity Priority FDA source
2025-01-30 Symbravo Axsome NDA #215431 Meloxicam; Rizatriptan Benzoate Type 4 - New Combination Standard FDA source
2025-01-28 Inzirqo Novitium Pharma NDA #219141 Hydrochlorothiazide Type 3 - New Dosage Form Standard FDA source
2025-01-24 Avtozma Celltrion Inc BLA #761420 Tocilizumab-anoh FDA source
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 syndrome Type 1 - New Molecular Entity Standard FDA source
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 disease FDA source
2025-01-17 Myinfla Columbia Therapeutics Inc NDA #216469 Colchicine Type 5 - New Formulation or New Manufacturer Standard FDA source
2025-01-16 Brynovin Azurity NDA #219122 Sitagliptin Hydrochloride Type 3 - New Dosage Form Standard FDA source