Calendar

Week of Feb 24, 2025

Feb 28, 2025approval534d agoONTRUZANT (TRASTUZUMAB-DTTB) — FDA approvalONTRUZANT

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

Feb 28, 2025approval534d agoAK-FLUOR 25% (FLUORESCEIN SODIUM) — FDA approvalLong Grove Pharmaceuticals LLC

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

Feb 28, 2025approval534d agoLYBALVI (OLANZAPINE) — FDA approval(olanzapine + samidorphan l-malate)

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

Feb 28, 2025approval534d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

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

Feb 28, 2025approval534d agoZILBRYSQ (ZILUCOPLAN SODIUM) — FDA approvalzilucoplan

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

Feb 28, 2025approval534d agoTYENNE (TOCILIZUMAB-AAZG) — FDA approvalTYENNE

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

Feb 28, 2025approval534d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

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

Feb 28, 2025approval534d agoOSENVELT (DENOSUMAB-BMWO) — FDA approvalOSENVELT

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

Feb 28, 2025approval534d agoEPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (EPINEPHRINE BITARTRATE) — FDA approvalepinephrine bitartrate

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

Feb 28, 2025approval534d agoULTOMIRIS (RAVULIZUMAB-CWVZ) — FDA approvalAlexion Pharmaceuticals Inc

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

Mar 3, 2025approval531d agoRIVAROXABAN — FDA approvalJohnson & Johnson Innovative Medicine

Sponsor: TARO. Form: TABLET. Route: ORAL

Mar 3, 2025approval

Mar 10, 2025approval524d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

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

Mar 10, 2025approval

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