| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215416 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214793 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761562 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761055 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218980 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761583 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215843 |
| 2026-02-13 |
Adquey |
Acrotech Biopharma Inc. |
NDA #216xxx |
Difamilast 1% |
To treat mild-to-moderate atopic dermatitis |
Type 1 - New Molecular Entity |
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216743 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219042 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218xxx |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216xxx |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217xxx |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761xxx |
| 2025-12-19 |
Myqorzo |
Cytokinetics, Inc. |
NDA #219083 |
Aficamten |
To treat symptomatic obstructive hypertrophic cardiomyopathy in adults |
Type 1 - New Molecular Entity |
Priority |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219083 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761xxx |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218571 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217xxx |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217xxx |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761434 |
| 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 |
Link |
| 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 |
Link |
| 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 |
|
|
Link |
| 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 |
Link |
| 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 |
Link |
| 2025-10-24 |
RESNIBEN |
Azurity Pharmaceuticals, Inc. |
NDA #220258 |
Cabozantinib |
|
|
Standard |
Link |
| 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 |
Link |
| 2025-10-24 |
Rocuronium Bromide |
Sterinova Inc. |
NDA #219108 |
Rocuronium Bromide |
Adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation |
|
|
Link |
| 2025-10-23 |
Blenrep |
GlaxoSmithKline LLC |
BLA #761440 |
Belantamab Mafodotin-blmf |
Treatment of adult patients with relapsed or refractory multiple myeloma |
|
|
Link |
| 2025-10-23 |
Javadin |
Azurity |
NDA #220256 |
Clonidine Hydrochloride |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-10-23 |
Dehydrated Alcohol |
Royal Pharmaceuticals, LLC. |
NDA #214988 |
Alcohol |
|
Type 5 - New Formulation or New Manufacturer |
Priority |
Link |
| 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 |
Link |
| 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 |
Link |
| 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 |
Link |
| 2025-10-07 |
Jascayd |
Boehringer Ingelheim |
NDA #218764 |
Nerandomilast |
Treatment of idiopathic pulmonary fibrosis in adult patients |
Type 1 - New Molecular Entity |
Priority |
Link |
| 2025-10-02 |
Eydenzelt |
Celltrion Inc |
BLA #761377 |
Aflibercept-boav |
|
|
|
Link |
| 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 |
Link |
| 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 |
Link |
| 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 |
Link |
| 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 |
Link |
| 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 |
Link |
| 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 |
Link |
| 2025-08-01 |
E-Z-Disk |
Bracco |
NDA #219840 |
Barium Sulfate |
|
|
Standard |
Link |
| 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 |
Link |
| 2025-08-08 |
Kyxata |
Avyxa Holdings |
NDA #219921 |
Carboplatin |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 2025-08-12 |
Brinsupri |
Insmed Inc |
NDA #217673 |
Brensocatib |
To treat non-cystic fibrosis bronchiectasis |
Type 1 - New Molecular Entity |
Priority |
Link |
| 2025-08-15 |
Cyklx |
American Genomics LLC |
NDA #218643 |
Articaine |
|
Type 3 - New Dosage Form and Type 4 - New Combination |
Standard |
Link |
| 2025-08-15 |
Tonmya |
Tonix Pharmaceuticals Inc |
NDA #219428 |
Cyclobenzaprine |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-07-03 |
Ekterly |
Kalvista |
NDA #219301 |
Sebetralstat |
To treat acute attacks of hereditary angioedema |
Type 1 - New Molecular Entity |
Standard |
Link |
| 2025-07-15 |
Kirsty |
Biocon Biologics Inc |
BLA #761188 |
Insulin Aspart-XJHZ |
|
|
|
Link |
| 2025-07-16 |
Famotidine |
Sagent |
NDA #219935 |
Famotidine |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
Link |
| 2025-07-23 |
Vostally |
Rosemont Pharms |
NDA #219757 |
Ramipril |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-07-24 |
Sdamlo |
Brillian Pharma |
NDA #219531 |
Amlodipine Besylate |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-07-24 |
Doptelet Sprinkle |
Akarx Inc |
NDA #219696 |
Avatrombopag Maleate |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 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 |
Link |
| 2025-07-29 |
Vyscoxa |
Codadose Inc |
NDA #211759 |
Celecoxib |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-07-30 |
Atmeksi |
Rosemont Pharms |
NDA #219843 |
Methocarbamol |
|
|
Standard |
Link |
| 2025-07-31 |
VIZZ |
LENZ Therap |
NDA #218585 |
Aceclidine Hydrochloride |
|
Type 1 - New Molecular Entity |
Standard |
Link |
| 2025-07-31 |
Alhemo |
Novo Nordisk Inc |
BLA #761428 |
Concizumab |
|
|
|
Link |
| 2025-06-05 |
Xifyrm |
Azurity |
NDA #218395 |
Meloxicam |
|
|
Standard |
Link |
| 2025-06-05 |
Widaplik |
George Medicines |
NDA #219423 |
Amlodipine Besylate; Indapamide; Telmisartan |
|
Type 4 - New Combination |
Standard |
Link |
| 2025-06-09 |
Rocuronium Bromide |
Fresenius Kabi USA |
NDA #217472 |
Rocuronium Bromide |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
|
|
Link |
| 2025-06-10 |
Brukinsa |
Beone Medicines USA |
NDA #218785 |
Zanubrutinib |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-06-11 |
Ibtrozi |
Nuvation |
NDA #219713 |
Taletrectinib Adipate |
|
Type 1 - New Molecular Entity |
Priority |
Link |
| 2025-06-12 |
Zusduri |
Urogen Pharma |
NDA #215793 |
Mitomycin |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-06-16 |
Arynta |
Azurity |
NDA #219847 |
Lisdexamfetamine Dimesylate |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-06-16 |
Carbon Dioxide, USP |
General Distributing Company |
NDA #220634 |
Carbon Dioxide |
|
|
Unknown |
Link |
| 2025-06-16 |
Andembry |
CSL Behring LLC |
BLA #761367 |
Garadacimab-gxii |
To prevent attacks of hereditary angioedema |
|
|
Link |
| 2025-06-18 |
Yeztugo |
Gilead Sciences Inc |
NDA #220018 |
Lenacapavir |
|
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Priority |
Link |
| 2025-06-18 |
Yeztugo |
Gilead Sciences Inc |
NDA #220020 |
Lenacapavir Sodium |
|
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Priority |
Link |
| 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 |
|
|
Link |
| 2025-06-27 |
Avgemsi |
Avyxa Holdings |
NDA #219920 |
Gemcitabine Hydrochloride |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 2025-05-08 |
Avmapki Fakzynja Co-pack (copackaged) |
Verastem Inc |
NDA #219616 |
Avutometinib Potassium; Defactinib Hydrochloride |
|
Type 1 - New Molecular Entity |
Priority |
Link |
| 2025-05-14 |
Brekiya (autoinjector) |
Amneal |
NDA #215400 |
Dihydroergotamine Mesylate |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
|
|
Link |
| 2025-05-20 |
Aususvar |
Auson Pharm |
NDA #217062 |
Rivaroxaban |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-05-22 |
Starjemza |
Bio-thera Solutions LTD |
BLA #761419 |
Ustekinumab-hmny |
|
|
|
Link |
| 2025-05-23 |
Yutrepia |
Liquidia Tech |
NDA #213005 |
Treprostinil Sodium |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
Link |
| 2025-05-28 |
Khindivi |
ETON |
NDA #218980 |
Hydrocortisone |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 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 |
Link |
| 2025-04-02 |
Libervant |
Aquestive |
NDA #218623 |
Diazepam |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-04-02 |
Vanrafia |
Novartis |
NDA #219208 |
Atrasentan Hydrochloride |
|
Type 1 - New Molecular Entity |
Standard |
Link |
| 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 |
Link |
| 2025-04-09 |
Trabectedin |
Ever Valinject |
NDA #219617 |
Trabectedin |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 2025-04-09 |
Jobevne |
Biocon Biologics Inc |
BLA #761175 |
Bevacizumab-NWGD |
|
|
|
Link |
| 2025-04-10 |
Lopressor |
Rubicon Research |
NDA #219373 |
Metoprolol Tartrate |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-04-10 |
Livmarli |
Mirum |
NDA #219485 |
Maralixibat Chloride |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-04-15 |
Mezofy |
CMG Pharm Co Ltd |
NDA #211448 |
Aripiprazole |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-04-17 |
Eliquis |
Bristol |
NDA #220073 |
Apixaban |
|
Type 3 - New Dosage Form |
Priority |
Link |
| 2025-04-17 |
Eliquis Sprinkle |
Bristol |
NDA #220073 |
Apixaban |
|
Type 3 - New Dosage Form |
Priority |
Link |
| 2025-04-21 |
Carbon Dioxide, USP |
Mitchell Wedling Supply |
NDA #220461 |
Carbon Dioxide |
|
|
|
Link |
| 2025-04-22 |
Qamzova |
Nanjing Delova |
NDA #217593 |
Meloxicam |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
|
|
Link |
| 2025-04-29 |
Imaavy |
Janssen Biotech |
BLA #761430 |
Nipocalimab-AAHU |
To treat generalized myasthenia gravis |
|
|
Link |
| 2025-04-30 |
Atzumi |
Satsuma Pharms |
NDA #217901 |
Dihydroergotamine Mesylate |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-03-03 |
Tevimbra |
Beigene |
BLA #761380 |
Islelizumab-jsgr |
|
|
|
Link |
| 2025-03-07 |
Omlyclo |
Celltrion Inc |
BLA #761399 |
Omalizumab-IGEC |
|
|
|
Link |
| 2025-03-13 |
Epinephrine |
Fresenius Kabi USA |
NDA #215425 |
Epinephrine |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 2025-03-13 |
Arbli |
Scienture |
NDA #218772 |
Losartan Potassium |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-03-14 |
Tyenne |
Fresenius Kabi USA |
BLA #761449 |
Tocilizumab-AAZG |
|
|
|
Link |
| 2025-03-17 |
Hemiclor |
PRM Pharma |
NDA #218647 |
Chlorthalidone |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-03-20 |
Gozellix |
Telix Innovations |
NDA #219592 |
Gallium Ga-68 Gozetotide |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 2025-03-25 |
Blujepa |
Glaxosmithkline |
NDA #218230 |
Gepotidacin Mesylate |
|
Type 1 - New Molecular Entity |
Priority |
Link |
| 2025-03-25 |
Bomyntra |
Fresenius Kabi USA LLC |
BLA #761398 |
Denosumab-bnht |
|
|
|
Link |
| 2025-03-25 |
Conexxence |
Fresenius Kabi USA LLC |
BLA #761398 |
Denosumab-bnht |
|
|
|
Link |
| 2025-03-25 |
Denosumab-bnht |
Fresenius Kabi USA LLC |
BLA #761398 |
Denosumab-bnht |
|
|
|
Link |
| 2025-03-26 |
Vykat XR |
Soleno Therap |
NDA #216665 |
Diazoxide Choline |
|
Type 2 - New Active Ingredient |
Priority |
Link |
| 2025-03-28 |
Qfitlia |
Genzyme Corp |
NDA #219019 |
Fitusiran Sodium |
|
Type 1 - New Molecular Entity |
Standard |
Link |
| 2025-02-02 |
Carbon Dioxide, USP |
Welders Supply Company of Louisville Inc |
NDA #220266 |
Carbon Dioxide |
|
Medical Gas |
|
Link |
| 2025-02-03 |
Onapgo |
MDD US |
NDA #214056 |
Apomorphine Hydrochloride |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 2025-02-07 |
Emblaveo |
Abbvie |
NDA #217906 |
Avibactam Sodium; Aztreonam |
|
Type 4 - New Combination |
Priority |
Link |
| 2025-02-11 |
Evrysdi |
Genentech Inc |
NDA #219285 |
Risdiplam |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 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 |
Link |
| 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 |
Link |
| 2025-02-13 |
Denosumab-dssb |
Samsung Bioepis Co Ltd |
BLA #761392 |
Denosumab-dssb |
|
|
|
Link |
| 2025-02-13 |
Ospomyv |
Samsung Bioepis Co Ltd |
BLA #761392 |
Denosumab-dssb |
|
|
|
Link |
| 2025-02-13 |
Xbryk |
Samsung Bioepis Co Ltd |
BLA #761392 |
Denosumab-dssb |
|
|
|
Link |
| 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 |
Link |
| 2025-02-14 |
Merilog |
Sanofi-Aventis US LLC |
BLA #761325 |
Insulin Aspart-szjj |
|
|
|
Link |
| 2025-02-14 |
Merilog Solostar |
Sanofi-Aventis US LLC |
BLA #761325 |
Insulin Aspart-szjj |
|
|
|
Link |
| 2025-02-19 |
Nilotinib D-Tartrate |
Cipla |
NDA #218922 |
Nilotinib D-tartrate |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 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 |
Link |
| 2025-02-21 |
Ctexli |
Mirum |
NDA #219488 |
Chenodiol |
|
Type 5 - New Formulation or New Manufacturer |
Priority |
Link |
| 2025-02-24 |
Miudella |
Sebela Womens HLTH |
NDA #218201 |
Copper |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
Link |
| 2025-02-28 |
Osenvelt |
Celltrion Inc |
BLA #761404 |
Denosumab-bmwo |
|
|
|
Link |
| 2025-02-28 |
Stoboclo |
Celltrion Inc |
BLA #761404 |
Denosumab-bmwo |
|
|
|
Link |
| 2025-01-16 |
Brynovin |
Azurity |
NDA #219122 |
Sitagliptin Hydrochloride |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-01-17 |
Myinfla |
Columbia Therapeutics Inc |
NDA #216469 |
Colchicine |
|
Type 5 - New Formulation or New Manufacturer |
Standard |
Link |
| 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 |
|
|
Link |
| 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 |
Link |
| 2025-01-24 |
Avtozma |
Celltrion Inc |
BLA #761420 |
Tocilizumab-anoh |
|
|
|
Link |
| 2025-01-28 |
Inzirqo |
Novitium Pharma |
NDA #219141 |
Hydrochlorothiazide |
|
Type 3 - New Dosage Form |
Standard |
Link |
| 2025-01-30 |
Symbravo |
Axsome |
NDA #215431 |
Meloxicam; Rizatriptan Benzoate |
|
Type 4 - New Combination |
Standard |
Link |
| 2025-01-30 |
Journavx |
Vertex Pharms Inc |
NDA #219209 |
Suzetrigine |
To treat moderate to severe acute pain |
Type 1 - New Molecular Entity |
Priority |
Link |