Treatment Watch

2591 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 (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006

200 events (showing first 200 — refine filters to narrow results)

Apr 20

2026

label expansion

DALFAMPRIDINE (DALFAMPRIDINE)

Multiple sclerosis· Accord Healthcare Inc.· ANDA206863

Apr 16

2026

label expansion

DUPIXENT (DUPILUMAB)FDA label ↗

Eosinophilic esophagitis· sanofi-aventis U.S. LLC· BLA761055

Apr 15

2026

FDA approval

METHOTREXATE (METHOTREXATE)

· Alembic Pharmaceuticals Inc.· ANDA220225

Apr 15

2026

label expansion

USTEKINUMAB (USTEKINUMAB)FDA label ↗

· Janssen Biotech, Inc.· BLA125261

Apr 15

2026

label expansion

ONDANSETRON HYDROCHLORIDE (ONDANSETRON HYDROCHLORIDE)

· Onesource Specialty Pharma Limited· ANDA078244

Apr 15

2026

FDA approval

GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)

· Teva Pharmaceuticals, Inc.· ANDA218738

Apr 15

2026

label expansion

ALENDRONATE SODIUM (ALENDRONATE SODIUM)

· Aurobindo Pharma Limited· ANDA090124

Apr 15

2026

label expansion

USTEKINUMAB (USTEKINUMAB)FDA label ↗

· Janssen Biotech, Inc.· BLA761044

Apr 15

2026

label expansion

WAINUA (EPLONTERSEN)FDA label ↗

Hereditary ATTR amyloidosis· AstraZeneca Pharmaceuticals LP· NDA217388

Apr 15

2026

FDA approval

GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE)

· Novadoz Pharmaceuticals LLC· ANDA219540

Apr 15

2026

FDA approval

DEXTROMETHORPHAN POLISTIREX (DEXTROMETHORPHAN POLISTIREX)

· Aurohealth LLC· ANDA218417

Apr 15

2026

label expansion

BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)

· Oxford Pharmaceuticals, LLC· ANDA075388

Apr 15

2026

label expansion

ZOLEDRONIC ACID (ZOLEDRONIC ACID)

· Mylan Institutional LLC· ANDA205254

Apr 14

2026

label expansion

CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)

· Saptalis Pharmaceuticals, LLC.· ANDA080983

Apr 14

2026

label expansion

MILNACIPRAN HYDROCHLORIDE (MILNACIPRAN HYDROCHLORIDE)

· Breckenridge Pharmaceutical, Inc.· ANDA205071

Apr 14

2026

label expansion

RYTELO (IMETELSTAT SODIUM)FDA label ↗

Myelodysplastic syndrome· Geron Corporation· NDA217779

Apr 14

2026

label expansion

ABREVA (DOCOSANOL)FDA label ↗

· Haleon US Holdings LLC· NDA020941

Apr 14

2026

label expansion

DANZITEN (NILOTINIB)FDA label ↗

Chronic myeloid leukemia· Azurity Pharmaceuticals, Inc.· NDA219293

Apr 14

2026

label expansion

BOSENTAN (BOSENTAN)

Pulmonary arterial hypertension· Zydus Pharmaceuticals USA Inc.· ANDA207760

Apr 14

2026

label expansion

BOSENTAN (BOSENTAN)

Pulmonary arterial hypertension· Actavis Pharma, Inc.· ANDA207110

Apr 14

2026

label expansion

KRISTALOSE (LACTULOSE)

· Cumberland Pharmaceuticals Inc.· ANDA074712

Apr 13

2026

label expansion

LAMOTRIGINE (LAMOTRIGINE)

Lennox-Gastaut syndrome· Alembic Pharmaceuticals Limited· ANDA090607

Apr 13

2026

label expansion

SPRAVATO (ESKETAMINE HYDROCHLORIDE)FDA label ↗

· Janssen Pharmaceuticals Inc.· NDA211243

Apr 13

2026

label expansion

VANFLYTA (QUIZARTINIB)FDA label ↗

Acute myeloid leukemia· Daiichi Sankyo Inc.· NDA216993

Apr 13

2026

label expansion

FILSPARI (SPARSENTAN)FDA label ↗

IgA Nephropathy· Travere Therapeutics, Inc.· NDA216403

Apr 10

2026

label expansion

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗

Isolated hyperchlorhidrosis· Janssen Pharmaceuticals, Inc.· NDA021121

Apr 10

2026

label expansion

METHYLPREDNISOLONE (METHYLPREDNISOLONE)

· Epic Pharma, LLC· ANDA204072

Apr 10

2026

label expansion

LAMOTRIGINE KIT (LAMOTRIGINE)

Lennox-Gastaut syndrome· OWP Pharmaceuticals, Inc.· ANDA078947

Apr 9

2026

FDA approval

FOSFOMYCIN TROMETHAMINE (FOSFOMYCIN TROMETHAMINE)

· Aucta Pharmaceuticals, Inc.· ANDA217772

Apr 9

2026

label expansion

ONUREG (AZACITIDINE)FDA label ↗

Juvenile myelomonocytic leukemia· Celgene Corporation· NDA214120

Apr 9

2026

label expansion

VABYSMO (FARICIMAB)FDA label ↗

· Genentech, Inc.· BLA761235

Apr 9

2026

label expansion

COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE)FDA label ↗

· Thea Pharma Inc.· NDA202667

Apr 9

2026

label expansion

REZENOPY (NALOXONE HCL)FDA label ↗

· Scienture LLC· NDA215487

Apr 9

2026

label expansion

DULOXETINE HYDROCHLORIDE (DULOXETINE)

· Alembic Pharmaceuticals Limited· ANDA202949

Apr 9

2026

label expansion

LAMOTRIGINE (LAMOTRIGINE)

Lennox-Gastaut syndrome· Aurobindo Pharma Limited· ANDA078956

Apr 8

2026

label expansion

LEVETIRACETAM SOLUTION (LEVETIRACETAM)

· Chartwell RX, LLC· ANDA090263

Apr 8

2026

label expansion

INGREZZA SPRINKLE (VALBENAZINE)FDA label ↗

Huntington disease· Neurocrine Biosciences, Inc.· NDA218390

Apr 8

2026

label expansion

VALPROIC ACID (VALPROIC ACID)

Juvenile absence epilepsy· Bionpharma Inc.· ANDA073484

Apr 7

2026

label expansion

BEYFORTUS (NIRSEVIMAB)FDA label ↗

· Sanofi Pasteur Inc.· BLA761328

Apr 7

2026

label expansion

SKYCLARYS (OMAVELOXOLONE)FDA label ↗

Friedreich ataxia· Biogen· NDA216718

Apr 7

2026

label expansion

PLUVICTO (LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN)FDA label ↗

· Novartis Pharmaceuticals Corporation· NDA215833

Apr 7

2026

label expansion

CEFEPIME HYDROCHLORIDE AND DEXTROSE (CEFEPIME HYDROCHLORIDE)FDA label ↗

· B. Braun Medical Inc.· NDA050821

Apr 7

2026

FDA approval

IVERMECTIN (IVERMECTIN)

· Ajanta Pharma USA Inc.· ANDA218509

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

· Sun Pharmaceutical Industries, Inc.· ANDA211491

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)FDA label ↗

· Ajanta Pharma USA Inc.· ANDA211482

Apr 6

2026

label expansion

KEYTRUDA (PEMBROLIZUMAB)FDA label ↗

Carcinoma of esophagus· Merck Sharp & Dohme LLC· BLA125514

Apr 6

2026

label expansion

IMATINIB MESYLATE (IMATINIB MESYLATE)

Myelodysplastic/myeloproliferative disease· BluePoint Laboratories· ANDA212773

Apr 6

2026

FDA approval

DAPAGLIFLOZIN (DAPAGLIFLOZIN)FDA label ↗

· Apotex Corp.· ANDA211523

Apr 6

2026

label expansion

KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH)FDA label ↗

· Merck Sharp & Dohme LLC· BLA761467

Apr 6

2026

FDA approval

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)

· Aurobindo Pharma Limited· ANDA211489

Apr 3

2026

label expansion

TYVASO (TREPROSTINIL)FDA label ↗

Pulmonary arterial hypertension· United Therapeutics Corporation· NDA022387

Apr 3

2026

FDA approval

PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)

· Baxter Healthcare Corporation· ANDA217032

Apr 2

2026

label expansion

ACETAZOLAMIDE (ACETAZOLAMIDE)

· Chartwell RX, LLC· ANDA205530

Apr 2

2026

label expansion

EYLEA HD (AFLIBERCEPT)FDA label ↗

Retinopathy of prematurity· Regeneron Pharmaceuticals, Inc· BLA761355

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

label expansion

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)

· Hospira, Inc.· ANDA088571

Apr 1

2026

label expansion

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)

· Hospira, Inc.· ANDA089651

Apr 1

2026

label expansion

LAMOTRIGINE (LAMOTRIGINE)

Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525

Apr 1

2026

label expansion

KESIMPTA (OFATUMUMAB)FDA label ↗

T-cell prolymphocytic leukemia· Novartis Pharmaceuticals Corporation· BLA125326

Apr 1

2026

label expansion

PROCHLORPERAZINE EDISYLATE (PROCHLORPERAZINE EDISYLATE)

· Somerset Therapeutics, LLC· ANDA212257

Apr 1

2026

label expansion

VAFSEO (VADADUSTAT)FDA label ↗

· Akebia Therapeutics, Inc.· NDA215192

Apr 1

2026

FDA approval

FOUNDAYO (ORFORGLIPRON)FDA label ↗

· Eli Lilly and Company· NDA220934

Apr 1

2026

label expansion

BOSENTAN (BOSENTAN)

Pulmonary arterial hypertension· Sun Pharmaceutical Industries, Inc.· ANDA209324

Mar 31

2026

label expansion

DEPAKOTE SPRINKLES (DIVALPROEX SODIUM)FDA label ↗

· AbbVie Inc.· NDA019680

Mar 31

2026

label expansion

VALPROATE SODIUM (VALPROATE SODIUM)

· Hikma Pharmaceuticals USA Inc.· ANDA078523

Mar 31

2026

label expansion

INBRIJA (LEVODOPA)FDA label ↗

· Merz Pharmaceuticals, LLC· NDA209184

Mar 31

2026

label expansion

DEPAKOTE (DIVALPROEX SODIUM)FDA label ↗

· AbbVie Inc.· NDA018723

Mar 31

2026

label expansion

DEPAKOTE ER (DIVALPROEX SODIUM)FDA label ↗

· AbbVie Inc.· NDA021168

Mar 31

2026

label expansion

VALPROIC ACID (VALPROIC ACID)

Juvenile absence epilepsy· Chartwell Governmental & Specialty RX, LLC.· ANDA075782

Mar 31

2026

label expansion

VALPROIC ACID (VALPROIC ACID)

Juvenile absence epilepsy· Xttrium Laboratories Inc.· ANDA070868

Mar 31

2026

label expansion

VALPROATE SODIUM (VALPROATE SODIUM)

· Sagent Pharmaceuticals· ANDA076295

Mar 30

2026

label expansion

BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE)

· Slate Run Pharmaceuticals, LLC· ANDA211347

Mar 30

2026

label expansion

BYOOVIZ (RANIBIZUMAB-NUNA)FDA label ↗

· BIOGEN INC.· BLA761202

Mar 30

2026

label expansion

ZYNYZ (RETIFANLIMAB-DLWR)FDA label ↗

Neuroendocrine tumor of anal canal· Incyte Corporation· BLA761334

Mar 30

2026

label expansion

FOCINVEZ (FOSAPREPITANT DIMEGLUMINE)FDA label ↗

· Steriscience Specialties Private Limited· NDA216686

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 30

2026

label expansion

LAMOTRIGINE (LAMOTRIGINE)

Lennox-Gastaut syndrome· Sun Pharmaceutical Industries, Inc.· ANDA078525

Mar 27

2026

label expansion

EPKINLY (EPCORITAMAB-BYSP)FDA label ↗

Follicular lymphoma· Genmab US, Inc.· BLA761324

Mar 27

2026

label expansion

TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA212273

Mar 27

2026

label expansion

SPINRAZA (NUSINERSEN)FDA label ↗

Spinal Muscular Atrophy· Biogen Inc.· NDA209531

Mar 27

2026

label expansion

TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA217660

Mar 27

2026

label expansion

LICART (DICLOFENAC EPOLAMINE)FDA label ↗

· IBSA Pharma Inc.· NDA206976

Mar 27

2026

label expansion

ALYFTREK (VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR)FDA label ↗

· Vertex Pharmaceuticals Incorporated· NDA218730

Mar 27

2026

label expansion

ALLI (ORLISTAT)FDA label ↗

· Haleon US Holdings LLC· NDA021887

Mar 27

2026

label expansion

ZEJULA (NIRAPARIB)FDA label ↗

Rare ovarian cancer· GlaxoSmithKline LLC· NDA214876

Mar 27

2026

label expansion

DAYBUE (TROFINETIDE)FDA label ↗

Post 5-alpha-reductase inhibitors treatment syndrome· Acadia Pharmaceuticals Inc.· NDA217026

Mar 27

2026

label expansion

CARDENE IV (NICARDIPINE HYDROCHLORIDE)FDA label ↗

· Baxter Healthcare Corporation· NDA019734

Mar 27

2026

label expansion

KETAMINE HYDROCHLORIDE (KETAMINE HYDROCHLORIDE)

Lethal Larsen-like syndrome· Gland Pharma Limited· ANDA216809

Mar 26

2026

label expansion

MEKINIST (TRAMETINIB)FDA label ↗

Non-small cell lung cancer· Novartis Pharmaceuticals Corporation· NDA204114

Mar 26

2026

label expansion

CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)FDA label ↗

X-linked hypophosphatemia· Pharmacia & Upjohn Company LLC· NDA050441

Mar 26

2026

label expansion

BKEMV (ECULIZUMAB-AEEB)FDA label ↗

Paroxysmal nocturnal hemoglobinuria· Amgen Inc· BLA761333

Mar 26

2026

label expansion

KADCYLA (ADO-TRASTUZUMAB EMTANSINE)FDA label ↗

· Genentech, Inc.· BLA125427

Mar 26

2026

FDA approval

AWIQLI (INSULIN ICODEC-ABAE)FDA label ↗

· Novo Nordisk· BLA761326

Mar 26

2026

label expansion

CLEOCIN HYDROCHLORIDE (CLINDAMYCIN HYDROCHLORIDE)FDA label ↗

· Pharmacia & Upjohn Company LLC· NDA050162

Mar 26

2026

label expansion

MEKINIST (TRAMETINIB)FDA label ↗

Non-small cell lung cancer· Novartis Pharmaceuticals Corporation· NDA217513

Mar 26

2026

label expansion

TAFINLAR (DABRAFENIB)FDA label ↗

Malignant lymphoma with peripheral neuropathy· Novartis Pharmaceuticals Corporation· NDA217514

Mar 26

2026

label expansion

NEFFY (EPINEPHRINE)FDA label ↗

X-linked immune dysregulation with inflammatory bowel disease due to ELF4 deficiency· ARS Pharmaceuticals Operations, Inc.· NDA214697

Mar 26

2026

label expansion

TAFINLAR (DABRAFENIB)FDA label ↗

Malignant lymphoma with peripheral neuropathy· Novartis Pharmaceuticals Corporation· NDA202806

Mar 25

2026

label expansion

ELREXFIO (ELRANATAMAB-BCMM)FDA label ↗

X-linked Ehlers-Danlos syndrome· U.S. Pharmaceuticals· BLA761345

Mar 25

2026

label expansion

WINREVAIR (SOTATERCEPT-CSRK)FDA label ↗

Pulmonary arterial hypertension· Merck Sharp & Dohme LLC· BLA761363

Mar 25

2026

label expansion

KRAZATI (ADAGRASIB)FDA label ↗

X-linked Ehlers-Danlos syndrome· Mirati Therapeutics, Inc· NDA216340

Mar 25

2026

label expansion

DRONABINOL (DRONABINOL)FDA label ↗

Robinow-like syndrome· Ascend Laboratories, LLC· NDA018651

Mar 25

2026

FDA approval

LIFYORLI (RELACORILANT)FDA label ↗

· Corcept Therapeutics Incorporated· NDA220641

Mar 25

2026

label expansion

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)

Isolated hyperchlorhidrosis· Granules Pharmaceuticals Inc.· ANDA210992

Mar 24

2026

label expansion

ZYRTEC (CETIRIZINE HYDROCHLORIDE)FDA label ↗

X-linked Ehlers-Danlos syndrome· Kenvue Brands LLC· NDA021621

Mar 24

2026

FDA approval

AVLAYAH (TIVIDENOFUSP ALFA-EKNM)FDA label ↗

· Denali Therapeutics Inc.· BLA761485

Mar 24

2026

label expansion

XARELTO (RIVAROXABAN)FDA label ↗

X-linked Ehlers-Danlos syndrome· Janssen Pharmaceuticals, Inc.· NDA022406

Mar 24

2026

label expansion

XARELTO (RIVAROXABAN)FDA label ↗

X-linked Ehlers-Danlos syndrome· Janssen Pharmaceuticals, Inc.· NDA215859

Mar 24

2026

label expansion

RINGERS (SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE)FDA label ↗

Achromatopsia· ICU Medical, Inc.· NDA018251

Mar 23

2026

label expansion

KETALAR (KETAMINE HYDROCHLORIDE)FDA label ↗

Lethal Larsen-like syndrome· Par Health USA, LLC· NDA016812

Mar 23

2026

label expansion

MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE)FDA label ↗

Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA021078

Mar 20

2026

label expansion

DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE)

Combined hyperlipidemia· Sun Pharmaceuticals Industries, Inc.· ANDA202126

Mar 20

2026

label expansion

KETALAR (KETAMINE HYDROCHLORIDE)

Lethal Larsen-like syndrome· Par Health USA, LLC· NDA016812

Mar 20

2026

label expansion

XEOMIN (INCOBOTULINUMTOXINA)FDA label ↗

X-linked Ehlers-Danlos syndrome· Merz Pharmaceuticals, LLC· BLA125360

Mar 20

2026

label expansion

OPDIVO (NIVOLUMAB)FDA label ↗

Peroxisomal acyl-CoA oxidase deficiency· E.R. Squibb & Sons, L.L.C.· BLA125554

Mar 20

2026

label expansion

EPIPEN (EPINEPHRINE)FDA label ↗

X-linked immune dysregulation with inflammatory bowel disease due to ELF4 deficiency· Viatris Specialty LLC· NDA019430

Mar 20

2026

label expansion

MEPRON (ATOVAQUONE)FDA label ↗

Laron syndrome with immunodeficiency· GlaxoSmithKline LLC· NDA020500

Mar 20

2026

FDA approval

ATOMOXETINE HYDROCHLORIDE (ATOMOXETINE HYDROCHLORIDE)FDA label ↗

· Advagen Pharma Ltd.· NDA220320

Mar 20

2026

label expansion

CARBAMAZEPINE (CARBAMAZEPINE)

Fetal carbamazepine syndrome· Alembic Pharmaceuticals Inc.· ANDA216623

Mar 19

2026

label expansion

EPINEPHRINE (EPINEPHRINE)FDA label ↗

X-linked immune dysregulation with inflammatory bowel disease due to ELF4 deficiency· Amneal Pharmaceuticals of New York LLC· NDA020800

Mar 19

2026

label expansion

CREXONT (CARBIDOPA AND LEVODOPA)FDA label ↗

Prader-Willi-like syndrome· Amneal Pharmaceuticals LLC· NDA217186

Mar 19

2026

label expansion

SINEMET (CARBIDOPA AND LEVODOPA)FDA label ↗

Prader-Willi-like syndrome· Organon LLC· NDA017555

Mar 19

2026

label expansion

IMCIVREE (SETMELANOTIDE)FDA label ↗

Citrullinemia· Rhythm Pharmaceuticals, Inc· NDA213793

Mar 19

2026

label expansion

DUOPA (CARBIDOPA AND LEVODOPA)FDA label ↗

Prader-Willi-like syndrome· AbbVie Inc.· NDA203952

Mar 19

2026

label expansion

CARBIDOPA, LEVODOPA, AND ENTACAPONE (CARBIDOPA, LEVODOPA, AND ENTACAPONE)FDA label ↗

Levodopa-unresponsive juvenile parkinsonism· Sandoz Inc· NDA021485

Mar 19

2026

label expansion

WEGOVY (SEMAGLUTIDE)FDA label ↗

Prader-Willi-like syndrome· Novo Nordisk· NDA218316

Mar 19

2026

label expansion

WEGOVY (SEMAGLUTIDE)FDA label ↗

Prader-Willi-like syndrome· Novo Nordisk· NDA215256

Mar 19

2026

FDA approval

FLAVALTA (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE)FDA label ↗

· Septodont, Inc.· NDA216564

Mar 19

2026

label expansion

VYALEV (FOSCARBIDOPA/FOSLEVODOPA)FDA label ↗

X-linked Ehlers-Danlos syndrome· AbbVie Inc.· NDA216962

Mar 19

2026

label expansion

DHIVY (CARBIDOPA LEVODOPA)FDA label ↗

X-linked Ehlers-Danlos syndrome· Avion Pharmaceuticals, LLC· NDA214869

Mar 19

2026

label expansion

CARBIDOPA AND LEVODOPA (CARBIDOPA AND LEVODOPA)FDA label ↗

Prader-Willi-like syndrome· Zydus Pharmaceuticals USA Inc.· NDA203312

Mar 18

2026

label expansion

VIGABATRIN (VIGABATRIN)

Neuroendocrine tumor of stomach· ENDO USA, Inc.· ANDA208218

Mar 18

2026

label expansion

MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL)

Mycophenolate mofetil embryopathy· Aurobindo Pharma Limited· ANDA218227

Mar 18

2026

label expansion

VIGADRONE (VIGABATRIN)

Neuroendocrine tumor of stomach· Upsher-Smith Laboratories, LLC· ANDA214749

Mar 18

2026

label expansion

VIGABATRIN (VIGABATRIN)

Neuroendocrine tumor of stomach· Aurobindo Pharma Limited· ANDA215601

Mar 18

2026

label expansion

VIGABATRIN (VIGABATRIN)

Neuroendocrine tumor of stomach· Amneal Pharmaceuticals NY LLC· ANDA210155

Mar 18

2026

label expansion

VIGABATRIN (VIGABATRIN)

Neuroendocrine tumor of stomach· Novadoz Pharmaceuticals LLC· ANDA215363

Mar 18

2026

label expansion

FEXOFENADINE HYDROCHLORIDE (FEXOFENADINE HYDROCHLORIDE)

· Pioneer Life Sciences, LLC· ANDA210137

Mar 18

2026

label expansion

CABERGOLINE (CABERGOLINE)

X-linked complex spastic paraplegia· SOLA Pharmaceuticals, LLC· ANDA076310

Mar 18

2026

label expansion

SKYRIZI (RISANKIZUMAB-RZAA)FDA label ↗

· AbbVie Inc.· BLA761105

Mar 18

2026

label expansion

POLIVY (POLATUZUMAB VEDOTIN)FDA label ↗

X-linked Ehlers-Danlos syndrome· Genentech, Inc.· BLA761121

Mar 18

2026

label expansion

SKYRIZI (RISANKIZUMAB-RZAA)FDA label ↗

· AbbVie Inc.· BLA761262

Mar 18

2026

label expansion

SABRIL (VIGABATRIN)FDA label ↗

Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA022006

Mar 18

2026

label expansion

PROSCAR (FINASTERIDE)FDA label ↗

· Organon LLC· NDA020180

Mar 18

2026

label expansion

INREBIC (FEDRATINIB HYDROCHLORIDE)FDA label ↗

Mixed neuroendocrine and non-neuroendocrine neoplasm of pancreas· Celgene Corporation· NDA212327

Mar 18

2026

label expansion

VIGAFYDE (VIGABATRIN)FDA label ↗

Neuroendocrine tumor of stomach· Upsher-Smith Laboratories, LLC· NDA217684

Mar 18

2026

label expansion

OJJAARA (MOMELOTINIB)FDA label ↗

Autosomal recessive non-syndromic intellectual disability· GlaxoSmithKline LLC· NDA216873

Mar 18

2026

label expansion

APRACLONIDINE (APRACLONIDINE)FDA label ↗

Congenital central hypoventilation syndrome· Sandoz Inc· NDA020258

Mar 18

2026

label expansion

IOPIDINE 1% (APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION)FDA label ↗

X-linked complex spastic paraplegia· Harrow Eye, LLC· NDA019779

Mar 18

2026

label expansion

SABRIL (VIGABATRIN)FDA label ↗

Neuroendocrine tumor of stomach· Lundbeck Pharmaceuticals LLC· NDA020427

Mar 18

2026

label expansion

VONJO (PACRITINIB)FDA label ↗

Conjoined twins· Sobi, Inc.· NDA208712

Mar 18

2026

label expansion

VIGABATRIN (VIGABATRIN)

Neuroendocrine tumor of stomach· Dr. Reddys Laboratories Inc.,· ANDA211481

Mar 18

2026

label expansion

VIGABATRIN (VIGABATRIN)

Neuroendocrine tumor of stomach· Dr. Reddys Laboratories Inc.,· ANDA211539

Mar 18

2026

label expansion

TOPIRAMATE (TOPIRAMATE)

Lennox-Gastaut syndrome· Ascend Laboratories, LLC· ANDA218482

Mar 18

2026

FDA approval

CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE)

X-linked hypophosphatemia· Aurobindo Pharma Limited· ANDA218942

Mar 17

2026

label expansion

OXALIPLATIN (OXALIPLATIN)

X-linked complex spastic paraplegia· Accord Healthcare Inc.· ANDA207474

Mar 17

2026

label expansion

ORKAMBI (LUMACAFTOR AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA206038

Mar 17

2026

label expansion

SYMDEKO (TEZACAFTOR AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA210491

Mar 17

2026

label expansion

GAMIFANT (EMAPALUMAB-LZSG)FDA label ↗

Infant botulism· Swedish Orphan Biovitrum AB (publ)· BLA761107

Mar 17

2026

label expansion

TOBRADEX ST (TOBRAMYCIN / DEXAMETHASONE)FDA label ↗

X-linked complex spastic paraplegia· Harrow Eye, LLC· NDA050818

Mar 17

2026

label expansion

TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA212273

Mar 17

2026

label expansion

TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA217660

Mar 17

2026

label expansion

ALYFTREK (VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR)FDA label ↗

· Vertex Pharmaceuticals Incorporated· NDA218730

Mar 17

2026

label expansion

COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)FDA label ↗

· Allergan, Inc.· NDA021398

Mar 17

2026

FDA approval

ICOTYDE (ICOTROKINRA)FDA label ↗

· Janssen Biotech, Inc.· NDA220149

Mar 17

2026

label expansion

KALYDECO (IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA203188

Mar 17

2026

label expansion

ORKAMBI (LUMACAFTOR AND IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA211358

Mar 17

2026

label expansion

AK-FLUOR (FLUORESCEIN)FDA label ↗

· Long Grove Pharmaceuticals, LLC· NDA022186

Mar 17

2026

label expansion

KALYDECO (IVACAFTOR)FDA label ↗

Cystic fibrosis· Vertex Pharmaceuticals Incorporated· NDA207925

Mar 16

2026

FDA approval

FLUTICASONE PROPIONATE ALLERGY RELIEF (FLUTICASONE PROPIONATE)

· GLENMARK THERAPEUTICS INC., USA· ANDA218742

Mar 16

2026

label expansion

NURTEC ODT (RIMEGEPANT SULFATE)FDA label ↗

Nodular regenerative hyperplasia of the liver· Pfizer Laboratories Div Pfizer Inc· NDA212728

Mar 16

2026

FDA approval

ERIBULIN MESYLATE (ERIBULIN MESYLATE)

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

Mar 13

2026

label expansion

BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE)

· Slate Run Pharmaceuticals, LLC· ANDA210015

Mar 13

2026

label expansion

GEMCITABINE (GEMCITABINE)

· Sagent Pharmaceuticals· ANDA209077

Mar 13

2026

label expansion

MEFENAMIC ACID (MEFENAMIC ACID)

· Micro Labs Limited· ANDA090562

Mar 13

2026

label expansion

ALLOPURINOL SODIUM (ALLOPURINOL SODIUM)

· Hikma Pharmaceuticals USA Inc.· ANDA076870

Mar 12

2026

label expansion

TRULICITY (DULAGLUTIDE)FDA label ↗

· Eli Lilly and Company· BLA125469

Mar 12

2026

label expansion

COSENTYX (SECUKINUMAB)FDA label ↗

· Novartis Pharmaceuticals Corporation· BLA761349

Mar 12

2026

label expansion

COSENTYX (SECUKINUMAB)FDA label ↗

· Novartis Pharmaceuticals Corporation· BLA125504

Mar 12

2026

label expansion

SOLIQUA 100/33 (INSULIN GLARGINE AND LIXISENATIDE)FDA label ↗

· Sanofi-Aventis U.S. LLC· BLA208673

Mar 12

2026

label expansion

SUNLENCA (LENACAPAVIR SODIUM)FDA label ↗

· Gilead Sciences, Inc.· NDA215974

Mar 12

2026

label expansion

SUNLENCA (LENACAPAVIR SODIUM)FDA label ↗

· Gilead Sciences, Inc.· NDA215973

Mar 11

2026

FDA approval

FERRIC CITRATE (FERRIC CITRATE)FDA label ↗

· Teva Pharmaceuticals, Inc.· ANDA212563

Mar 11

2026

label expansion

EQUATE LANSOPRAZOLE (LANSOPRAZOLE)FDA label ↗

· Wal-Mart Stores Inc· NDA208025

Mar 11

2026

label expansion

APHEXDA (MOTIXAFORTIDE)FDA label ↗

Complications after hematopoietic stem cell transplantation· Gamida Cell Inc.· NDA217159

Mar 11

2026

label expansion

BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE)FDA label ↗

Glycogen storage disease due to acid maltase deficiency· BJWC· NDA209400

Mar 11

2026

label expansion

OZURDEX (DEXAMETHASONE)FDA label ↗

Multiple myeloma· Allergan, Inc.· NDA022315

Mar 10

2026

label expansion

ARCALYST (RILONACEPT)FDA label ↗

NLRP3-associated autoinflammatory disease· Kiniksa Pharmaceuticals (UK), Ltd.· BLA125249

Mar 10

2026

label expansion

OGSIVEO (NIROGACESTAT)FDA label ↗

Desmoid tumor· SpringWorks Therapeutics, Inc.· NDA217677

Mar 10

2026

label expansion

CARBINOXAMINE MALEATE EXTENDED-RELEASE ORAL SUSPENSION (CARBINOXAMINE MALEATE)FDA label ↗

· Neos Therapeutics, LP· NDA022556

Mar 10

2026

label expansion

DOXORUBICIN HYDROCHLORIDE LIPOSOME (DOXORUBICIN HYDROCHLORIDE LIPOSOME)FDA label ↗

· Baxter Healthcare Company· NDA050718

Mar 10

2026

label expansion

QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE)FDA label ↗

Isolated hyperchlorhidrosis· NextWave Pharmaceuticals, Inc· NDA207960

Mar 10

2026

label expansion

ALEVE GELCAPS (NAPROXEN SODIUM)FDA label ↗

· Bayer HealthCare LLC.· NDA020204

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.