Calendar

Week of Feb 24, 2025

Feb 24, 2025approval536d agoSULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE) — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Feb 24, 2025approval536d agoPOSACONAZOLE — FDA approvalPOSACONAZOLE

Sponsor: MSN. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗

Feb 24, 2025approval536d agoMIUDELLA (COPPER) — FDA approval

Sponsor: SEBELA WOMENS HLTH. Form: SYSTEM. Route: INTRAUTERINE

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Feb 25, 2025approval535d agoSTIVARGA (REGORAFENIB) — FDA approvalBayer AG

Sponsor: BAYER HLTHCARE. Form: TABLET. Route: ORAL

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Feb 26, 2025approval534d agoSONAZINE (CHLORPROMAZINE HYDROCHLORIDE) — FDA approvalSaptalis Pharmaceuticals LLC

Sponsor: SAPTALIS PHARMS. Form: CONCENTRATE. Route: ORAL

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Feb 26, 2025approval534d agoTEPYLUTE (THIOTEPA) — FDA approvalSTI Pharma LLC

Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS

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Feb 27, 2025approval533d agoPADCEV (ENFORTUMAB VEDOTIN-EJFV) — FDA approvalenfortumab vedotin

Sponsor: ASTELLAS. Form: INJECTABLE. Route: INJECTION

full page →enfortumab vedotin →fda approvals ↗

Feb 28, 2025approval532d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

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

full page →ONTRUZANT →fda approvals ↗

Feb 28, 2025approval532d agoAK-FLUOR 25% (FLUORESCEIN SODIUM) — FDA approvalLong Grove Pharmaceuticals LLC

Sponsor: LONG GROVE PHARMS. Form: INJECTABLE. Route: INTRAVENOUS

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Feb 28, 2025approval532d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

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

full page →(olanzapine + samidorphan l-malate) →fda approvals ↗

Feb 28, 2025approval532d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

full page →zilucoplan →fda approvals ↗

Feb 28, 2025approval532d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

Sponsor: UCB INC. Form: SOLUTION. Route: SUBCUTANEOUS

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Feb 28, 2025approval532d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS

full page →TYENNE →fda approvals ↗

Feb 28, 2025approval532d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

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Feb 28, 2025approval532d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

full page →OSENVELT →fda approvals ↗

Feb 28, 2025approval532d agoEPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (EPINEPHRINE BITARTRATE) — FDA approvalepinephrine bitartrate

Sponsor: BAXTER HLTHCARE CORP. Form: SOLUTION. Route: INTRAVENOUS

full page →epinephrine bitartrate →fda approvals ↗

Feb 28, 2025approval532d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

Sponsor: ALEXION PHARM. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Week of Mar 3, 2025

Mar 3, 2025approval529d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

Sponsor: TARO. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Mar 3, 2025approval

Week of Mar 10, 2025

Mar 10, 2025approval522d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗

Mar 10, 2025approval

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