Calendar

pharmadog

Week of Dec 1, 2025

Dec 1, 2025approval271d agoCEFAZOLIN SODIUM — FDA approvalSamson Medical Technologies LLC

Sponsor: HIKMA FARMACEUTICA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 1, 2025approval271d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

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

full page →fda approvals ↗

Dec 1, 2025approval271d agoOMLYCLO (OMALIZUMAB-IGEC) — FDA approvalomalizumab biosimilar

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INJECTION

full page →omalizumab biosimilar →fda approvals ↗

Dec 1, 2025approval271d agoALBUTEROL SULFATE — FDA approvalGlaxoSmithKline LLC

Sponsor: AMNEAL IRELAND LTD. Form: AEROSOL, METERED. Route: INHALATION

full page →fda approvals ↗

Dec 2, 2025approval270d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 2, 2025approval270d agoTEVIMBRA (TISLELIZUMAB-JSGR) — FDA approvalBeOne Medicines Ltd.

Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION

full page →fda approvals ↗

Dec 2, 2025approval270d agoOLANZAPINE — FDA approvalTorrent Pharma Inc

Sponsor: TORRENT PHARMS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval270d agoJAYPIRCA (PIRTOBRUTINIB) — FDA approvalEli Lilly and Co

Sponsor: LOXO ONCOL. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 2, 2025approval270d agoPROPOFOL — FDA approvalBika Biotechnology Guanzhou Co Ltd

Sponsor: NANJING KING FRIEND. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 2, 2025approval270d agoLEVETIRACETAM — FDA approvalLEVETIRACETAM

Sponsor: KNACK. Form: INJECTABLE. Route: INTRAVENOUS

full page →LEVETIRACETAM →fda approvals ↗

Dec 2, 2025approval270d agoSITAGLIPTIN AND METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) — FDA approvalmetformin hydrochloride ER

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →metformin hydrochloride ER →fda approvals ↗

Dec 3, 2025approval269d agoERTUGLIFLOZIN — FDA approvalERTUGLIFLOZIN

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

full page →ERTUGLIFLOZIN →fda approvals ↗

Dec 3, 2025approval269d agoMACITENTAN — FDA approvalJOHNSON & JOHNSON

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

full page →fda approvals ↗

Dec 3, 2025approval269d agoMACITENTAN — FDA approvalMACITENTAN

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →MACITENTAN →fda approvals ↗

Dec 3, 2025approval269d agoOLANZAPINE — FDA approvalolanzapine ODT

Sponsor: TORRENT. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL

full page →olanzapine ODT →fda approvals ↗

Dec 4, 2025approval268d agoEPLERENONE — FDA approvalEPLERENONE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →EPLERENONE →fda approvals ↗

Dec 4, 2025approval268d agoTOPIRAMATE — FDA approvaltopiramate ER

Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

full page →topiramate ER →fda approvals ↗

Dec 5, 2025approval267d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

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

full page →ONTRUZANT →fda approvals ↗

Dec 5, 2025approval267d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.