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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 Aug 3, 2026

1

08/07/2026adcom23d agoAdvisory Committee Calendar

This page contains notices of advisory committee meetings. Refer to the individual meeting link below for more information on the anticipated format of each meeting. For previous years' advisory committee calendars, see the FDA Archive.

full page →fda adcom ↗

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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