| 2025-11-19 |
Hyrnuo |
Bayer Healthcare Pharms |
NDA #219947 |
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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219972 |
| 2025-11-18 |
Redemplo |
Arrowhead Pharmaceuticals, Inc. |
NDA #219947 |
plozasrian |
ATo reduce triglycerides in adults with familial chylomicronemia syndrome |
Type 1 - New Molecular Entity |
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219947/ |
| 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 |
|
|
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761450 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220305 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219792 |
| 2025-10-24 |
RESNIBEN |
Azurity Pharmaceuticals, Inc. |
NDA #220258 |
cabozantinib |
|
|
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220258 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219469 |
| 2025-10-24 |
rocuronium bromide |
Sterinova Inc. |
NDA #219108 |
rocuronium bromide |
Adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation |
|
|
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219108 |
| 2025-10-02 |
Eydenzelt |
Celltrion Inc |
BLA #761377 |
AFLIBERCEPT-BOAV |
|
|
|
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761377 |
| 2025-10-07 |
Jascayd |
Boehringer Ingelheim |
NDA #218764 |
nerandomilast |
Treatment of idiopathic pulmonary fibrosis in adult patients |
Type 1 - New Molecular Entity |
Priority |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218764 |
| 2025-10-23 |
Blenrep |
GlaxoSmithKline LLC |
BLA #761440 |
belantamab mafodotin-blmf |
Treatment of adult patients with relapsed or refractory multiple myeloma |
|
|
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761440 |
| 2025-10-23 |
Javadin |
Azurity |
NDA #220256 |
clonodine hydrochloride |
|
Type 3 - New Dosage Form |
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220256 |
| 2025-10-23 |
Dehydrated Alcohol |
Royal Pharmaceuticals, LLC. |
NDA #214988 |
alcohol |
|
Type 5 - New Formulation or New Manufacturer |
Priority |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214988 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212271 |
| 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, in conjunction with the O2n System and the Boost Goggles |
Type 5 - New Formulation or New Manufacturer |
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219910 |
| 2025-10-16 |
Ferabright |
Covis Pharma US |
NDA #219868 |
ferumoxytol |
Use for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219868 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219685 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215244 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761467 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218881 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219070 |
| 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 |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218436 |
| 2025-10-24 |
Lynkuet |
Bayer HealthCare Pharmaceuticals Inc. |
NDA #219469 |
Elinzanetant |
To treat moderate to severe vasomotor symptoms (hot flashes) due to menopause |
Type 1 - New Molecular Entity |
Standard |
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219469 |
| 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 |