Calendar

Week of Nov 3, 2025

Nov 5, 2025approval298d agoUNASYN (AMPICILLIN SODIUM) — FDA approvalUNASYN

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

Nov 6, 2025approval297d agoDARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ) — FDA approval(daratumumab + hyaluronidase (human recombinant))

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →(daratumumab + hyaluronidase (human recombinant)) →fda approvals ↗

Nov 6, 2025approval297d agoVOQUEZNA (VONOPRAZAN FUMARATE) — FDA approvalvonoprazan fumarate

Sponsor: PHATHOM. Form: TABLET. Route: ORAL

full page →vonoprazan fumarate →fda approvals ↗

Nov 6, 2025approval297d agoSUMATRIPTAN SUCCINATE — FDA approvalSUMATRIPTAN SUCCINATE

Sponsor: ALEMBIC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →SUMATRIPTAN SUCCINATE →fda approvals ↗

Nov 6, 2025approval297d agoSIMLANDI (ADALIMUMAB-RYVK) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: PH HEALTH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: CHARTWELL RX. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 6, 2025approval297d agoPIPERACILLIN (PIPERACILLIN SODIUM) — FDA approvalIstituto Biochimico Italiano Giovanni Lorenzini Spa

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 6, 2025approval297d agoCETRORELIX ACETATE — FDA approvalEMD Serono Inc

Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 6, 2025approval297d agoCETRORELIX ACETATE — FDA approvalEMD Serono Inc

Sponsor: TEVA PHARMS INC. Form: POWDER. Route: SUBCUTANEOUS

full page →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: SANDOZ. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 6, 2025approval297d agoPIPERACILLIN (PIPERACILLIN SODIUM) — FDA approvalIstituto Biochimico Italiano Giovanni Lorenzini Spa

Sponsor: ISTITUTO BIO ITA SPA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 6, 2025approval297d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: STERISCIENCE. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Nov 6, 2025approval297d agoDASATINIB — FDA approvalDASATINIB

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →DASATINIB →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalSciegen Pharmaceuticals Inc

Sponsor: SCIEGEN PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 6, 2025approval297d agoNELARABINE — FDA approvalNELARABINE

Sponsor: AMNEAL. Form: INJECTABLE. Route: INTRAVENOUS

full page →NELARABINE →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalBUPROPION HYDROCHLORIDE

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

full page →BUPROPION HYDROCHLORIDE →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗

Nov 6, 2025approval297d agoBUPROPION HYDROCHLORIDE — FDA approvalIpca Pharmaceuticals Inc

Sponsor: ACTAVIS LABS FL INC. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Nov 7, 2025approval296d agoLAZCLUZE (LAZERTINIB MESYLATE) — FDA approvallazertinib mesylate

Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL

full page →lazertinib mesylate →fda approvals ↗

Nov 7, 2025approval296d agoRYBREVANT (AMIVANTAMAB-VMJW) — FDA approvalamivantamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →amivantamab →fda approvals ↗

Week of Nov 10, 2025

Nov 10, 2025approval293d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗

Nov 10, 2025approval

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Week of Nov 3, 2025

Week of Nov 10, 2025