Treatment Watch

2715 eventsUpdated today

FDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.

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FDA data is sourced from FDA.gov and openFDA.

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All events FDA approval (620)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All 2026 2025 2024 2023 2022 2021 2020 2019 2018 2017

63 events · FDA approval · 2026

Apr 15

2026

FDA approval

METHOTREXATE (METHOTREXATE)

· Alembic Pharmaceuticals Inc.· ANDA220225

Apr 15

2026

FDA approval

ATROPINE SULFATE (ATROPINE SULFATE)

· Edenbridge Pharmaceuticals LLC.· ANDA219013

Apr 15

2026

FDA approval

DEXTROMETHORPHAN POLISTIREX (DEXTROMETHORPHAN POLISTIREX)

· Aurohealth LLC· ANDA218417

Apr 15

2026

FDA approval

GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)

· Teva Pharmaceuticals, Inc.· ANDA218738

Apr 15

2026

FDA approval

GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)

· Novadoz Pharmaceuticals LLC· ANDA219540

Apr 9

2026

FDA approval

FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)

· Aucta Pharmaceuticals, Inc.· ANDA217772

Apr 7

2026

FDA approval

IVERMECTIN (IVERMECTIN)

· Ajanta Pharma USA Inc.· ANDA218509

Apr 6

2026

FDA approval

DAPAGLIFLOZIN AND SAXAGLIPTIN (DAPAGLIFLOZIN AND SAXAGLIPTIN)FDA label ↗

· Novadoz Pharmaceuticals LLC· ANDA211533

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)FDA label ↗

· Ajanta Pharma USA Inc.· ANDA211482

Apr 6

2026

FDA approval

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)FDA label ↗

· Sun Pharmaceutical Industries, Inc.· ANDA211491

Apr 6

2026

FDA approval

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)

· Aurobindo Pharma Limited· ANDA211489

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)

· Lupin Pharmaceuticals, Inc.· ANDA211531

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)

· Cipla USA Inc.· ANDA211535

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)FDA label ↗

· Florida Pharmaceutical Products, LLC· ANDA211156

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)

· Macleods Pharmaceuticals Limited· ANDA211506

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)FDA label ↗

· Apotex Corp.· ANDA211523

Apr 3

2026

FDA approval

PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)

· Baxter Healthcare Corporation· ANDA217032

Apr 2

2026

FDA approval

NINTEDANIB (NINTEDANIB)

Idiopathic pulmonary fibrosis· Edenbridge Pharmaceuticals LLC.· ANDA219819

Apr 2

2026

FDA approval

NINTEDANIB (NINTEDANIB)

Idiopathic pulmonary fibrosis· Sandoz Inc· ANDA216915

Apr 2

2026

FDA approval

NINTEDANIB (NINTEDANIB)

Idiopathic pulmonary fibrosis· Dr. Reddy's Laboratories Inc.· ANDA219283

Apr 2

2026

FDA approval

NINTEDANIB (NINTEDANIB)FDA label ↗

Idiopathic pulmonary fibrosis· Apotex Corp.· ANDA219227

Apr 1

2026

FDA approval

FOUNDAYO (ORFORGLIPRON)FDA label ↗

· Eli Lilly and Company· NDA220934

Mar 30

2026

FDA approval

EPINEPHRINE (EPINEPHRINE)FDA label ↗

X-linked immune dysregulation with inflammatory bowel disease due to ELF4 deficiency· Baxter Healthcare Corporation· NDA220626

Mar 26

2026

FDA approval

AWIQLI (INSULIN ICODEC-ABAE)FDA label ↗

· Novo Nordisk· BLA761326

Mar 25

2026

FDA approval

LIFYORLI (RELACORILANT)FDA label ↗

· Corcept Therapeutics Incorporated· NDA220641

Mar 24

2026

FDA approval

AVLAYAH (TIVIDENOFUSP ALFA-EKNM)FDA label ↗

· Denali Therapeutics Inc.· BLA761485

Mar 20

2026

FDA approval

ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE HYDROCHLORIDE)FDA label ↗

· Advagen Pharma Ltd.· NDA220320

Mar 19

2026

FDA approval

FLAVALTA (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)FDA label ↗

· Septodont, Inc.· NDA216564

Mar 18

2026

FDA approval

CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)

X-linked hypophosphatemia· Aurobindo Pharma Limited· ANDA218942

Mar 17

2026

FDA approval

ICOTYDE (ICOTROKINRA)FDA label ↗

· Janssen Biotech, Inc.· NDA220149

Mar 16

2026

FDA approval

FLUTICASONE PROPIONATE ALLERGY RELIEF (FLUTICASONE PROPIONATE)

· GLENMARK THERAPEUTICS INC., USA· ANDA218742

Mar 16

2026

FDA approval

ERIBULIN MESYLATE (ERIBULIN MESYLATE)

Alveolar soft tissue sarcoma· XGen Pharmaceuticals DJB, Inc.· ANDA219054

Mar 11

2026

FDA approval

FERRIC CITRATE (FERRIC CITRATE)FDA label ↗

· Teva Pharmaceuticals, Inc.· ANDA212563

Mar 5

2026

FDA approval

CHOLESTYRAMINE (CHOLESTYRAMINE)

· Micro Labs Limited· ANDA219318

Mar 3

2026

FDA approval

FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)FDA label ↗

· Glenmark Pharmaceuticals Inc., USA· ANDA219602

Feb 27

2026

FDA approval

YUVIWEL (NAVEPEGRITIDE)FDA label ↗

Achondroplasia· Ascendis Pharma Endocrinology, Inc.· NDA219164

Feb 27

2026

FDA approval

DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)FDA label ↗

· Macleods Pharmaceuticals Limited· ANDA218744

Feb 26

2026

FDA approval

DAPSONE (DAPSONE)

· Viona Pharmaceuticals Inc· ANDA220103

Feb 25

2026

FDA approval

DESMODA (DESMOPRESSIN ACETATE ORAL SOLUTION)FDA label ↗

· Eton Pharmaceuticals, Inc.· NDA219873

Feb 24

2026

FDA approval

PREGABALIN (PREGABALIN)

· FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED· ANDA218529

Feb 24

2026

FDA approval

LIRAGLUTIDE (LIRAGLUTIDE)

· Biocon Pharma Inc.· ANDA217063

Feb 23

2026

FDA approval

BRIVARACETAM (BRIVARACETAM)FDA label ↗

· Novadoz Pharmaceuticals LLC· ANDA214924

Feb 23

2026

FDA approval

BRIVARACETAM (BRIVARACETAM INJECTION)

· PAI Holdings, LLC dba PAI Pharma· ANDA218249

Feb 23

2026

FDA approval

LOARGYS (PEGZILARGINASE-NBLN)FDA label ↗

Rare deficiency anemia· Immedica Pharma US Inc.· BLA761211

Feb 23

2026

FDA approval

IPRATROPIUM BROMIDE INHALATION (IPRATROPIUM BROMIDE INHALATION)FDA label ↗

· Armstrong Pharmaceuticals, Inc.· ANDA217953

Feb 23

2026

FDA approval

BRIVARACETAM (BRIVARACETAM)

· Lupin Pharmaceuticals, Inc.· ANDA220164

Feb 20

2026

FDA approval

FAVLYXA (FLUOROURACIL)FDA label ↗

· Avyxa Pharma, LLC· NDA220201

Feb 19

2026

FDA approval

BRIVARACETAM (BRIVARACETAM)FDA label ↗

· Novadoz Pharmaceuticals LLC· ANDA214922

Feb 18

2026

FDA approval

ARIPIPRAZOLE (ARIPIPRAZOLE)

Tourette syndrome· Aurobindo Pharma Limited· ANDA216208

Feb 17

2026

FDA approval

BOSENTAN (BOSENTAN)

Pulmonary arterial hypertension· Zydus Pharmaceuticals USA Inc.· ANDA213981

Feb 13

2026

FDA approval

AVOPEF (ETOPOSIDE)FDA label ↗

· Avyxa Pharma, LLC· NDA220200

Feb 13

2026

FDA approval

METRONIDAZOLE (METRONIDAZOLE)

· Viona Pharmaceuticals Inc· ANDA220095

Feb 13

2026

FDA approval

RYBREVANT FASPRO (AMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT))FDA label ↗

· Janssen Biotech, Inc.· BLA761484

Feb 12

2026

FDA approval

DIFAMILAST (ADQUEY)FDA label ↗

· Acrotech Biopharma Inc· NDA219474

Feb 5

2026

FDA approval

BUMETANIDE (BUMETANIDE)

· Novadoz Pharmaceuticals LLC· ANDA215362

Feb 3

2026

FDA approval

VYKOURA (LEUCOVORIN CALCIUM)FDA label ↗

Syndrome with difference of sex development of gynecological interest· Avyxa Pharma, LLC· NDA220406

Feb 2

2026

FDA approval

FIDAXOMICIN (FIDAXOMICIN)

Congenital enterovirus infection· Apotex Corp.· ANDA219559

Jan 29

2026

FDA approval

SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)

· Zydus Pharmaceuticals (USA) Inc.· ANDA220275

Jan 28

2026

FDA approval

YUVEZZI (CARBACHOL AND BRIMONIDINE TARTRATE)FDA label ↗

· Visus Therapeutics, Inc.· NDA220142

Jan 28

2026

FDA approval

SERTRALINE HCL (SERTRALINE)

· Amneal Pharmaceuticals NY LLC· ANDA219655

Jan 27

2026

FDA approval

PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)

· Lifestar Pharma LLC· ANDA216663

Jan 26

2026

FDA approval

QUIOFIC (FOLIC ACID)FDA label ↗

· Solubiomix, LLC· NDA216395

Jan 12

2026

FDA approval

ZYCUBO (COPPER HISTIDINATE)FDA label ↗

Marburg hemorrhagic fever· Sentynl Therapeutics, Inc.· NDA211241

Not medical advice — always consult your healthcare provider before making treatment decisions.

Data sourced from FDA.gov and openFDA, updated daily. Dates are subject to change. Always verify with FDA.gov for official decisions.