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Week of Apr 13, 2026

32

Apr 15, 2026approval137d agoATROPINE SULFATE — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUSPIRONE HYDROCHLORIDE — FDA approvalOxford Pharmaceuticals LLC

Sponsor: OXFORD PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoCOLESTIPOL HYDROCHLORIDE — FDA approvalCarnegie Pharmaceuticals LLC

Sponsor: IMPAX LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: POWDER. Route: IV (INFUSION)

full page →ONTRUZANT →fda approvals ↗

Apr 15, 2026approval137d agoDEXMEDETOMIDINE HYDROCHLORIDE — FDA approvalDEXMEDETOMIDINE HYDROCHLORIDE

Sponsor: BAXTER HLTHCARE CORP. Form: INJECTABLE. Route: INJECTION

full page →DEXMEDETOMIDINE HYDROCHLORIDE →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalIGC Pharma, Inc.

Sponsor: DR REDDYS LABS SA. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →fda approvals ↗

Apr 15, 2026approval137d agoDATSCAN (IOFLUPANE I-123) — FDA approval

Sponsor: GE HLTHCARE INC. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Apr 15, 2026approval137d agoITOVEBI (INAVOLISIB) — FDA approvalinavolisib

Sponsor: GENENTECH INC. Form: TABLET. Route: ORAL

full page →inavolisib →fda approvals ↗

Apr 16, 2026approval136d agoBRIMONIDINE TARTRATE — FDA approvalLumify

Sponsor: MANKIND PHARMA. Form: SOLUTION/DROPS. Route: OPHTHALMIC

full page →Lumify →fda approvals ↗

Apr 16, 2026approval136d agoSELEXIPAG — FDA approvalSELEXIPAG

Sponsor: RK PHARMA. Form: TABLET. Route: ORAL

full page →SELEXIPAG →fda approvals ↗

Apr 16, 2026approval136d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗

Apr 17, 2026approval135d agoSODIUM ACETATE — FDA approvalSODIUM ACETATE

Sponsor: EXTROVIS. Form: SOLUTION. Route: INTRAVENOUS

full page →SODIUM ACETATE →fda approvals ↗

Apr 17, 2026approval135d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval135d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval135d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval135d agoCOSENTYX (SECUKINUMAB) — FDA approvalNOVARTIS AG

Sponsor: NOVARTIS PHARMS CORP. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Apr 17, 2026approval135d agoVALPROIC ACID — FDA approvalVALPROIC ACID

Sponsor: QUAGEN. Form: SYRUP. Route: ORAL

full page →VALPROIC ACID →fda approvals ↗

Apr 17, 2026approval135d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: YICHANG HUMANWELL. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Apr 17, 2026approval135d agoCALCIPOTRIENE — FDA approvalPrasco LLC

Sponsor: GLENMARK SPECLT. Form: CREAM. Route: TOPICAL

full page →fda approvals ↗

Apr 17, 2026approval135d agoESOMEPRAZOLE MAGNESIUM — FDA approvalesomeprazole magnesium DR

Sponsor: MARKSANS PHARMA. Form: CAPSULE, DELAYED RELEASE. Route: ORAL

full page →esomeprazole magnesium DR →fda approvals ↗

Apr 17, 2026approval135d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval135d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

Sponsor: GLENMARK PHARMS LTD. Form: TABLET, FOR SUSPENSION. Route: ORAL

full page →LAMOTRIGINE →fda approvals ↗

Apr 17, 2026approval135d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

Sponsor: IMPAX LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Apr 17, 2026approval135d agoTETRACYCLINE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals of New York LLC

Sponsor: IMPAX LABS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Week of Apr 20, 2026

3

Apr 20, 2026approval132d agoCANAGLIFLOZIN — FDA approvalCANAGLIFLOZIN

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL

full page →CANAGLIFLOZIN →fda approvals ↗

Apr 20, 2026approval

Week of Apr 27, 2026

4

Apr 27, 2026pdufa125d agoRegeneron Pharmaceuticals Inc — dupilumab (PDUFA)dupilumab

Therapy area: Dermatology. Indication: Chronic Urticaria

full page →dupilumab →source: globaldata

Apr 28, 2026pdufa

Week of Jul 13, 2026

1

Jul 17, 2026pdufa44d agoPDUFA — 2026-07-17

Prescription Drug User Fee Act goal date of July 17, 2026

full page →pdufa extract ↗

Week of Jan 4, 2027

1

Jan 4, 2027pdufa127dPDUFA — 2027-01-04

action date of January 4, 2027

full page →pdufa extract ↗

Week of Jan 18, 2027

1

Jan 21, 2027pdufa144dPDUFA — 2027-01-21Ultragenyx Pharmaceutical Inc.

action date of Jan. 21, 2027

full page →pdufa extract ↗

Date TBD

2

TBDapprovalOZURDEX (DEXAMETHASONE) — FDA approvaldexamethasone LA

Sponsor: ABBVIE. Form: IMPLANT. Route: INTRAVITREAL

full page →dexamethasone LA →fda approvals ↗

TBDapproval

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