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FDA BLA · BLA761137

PADCEV EJFV

enfortumab vedotin

Sponsor: ASTELLAS

APPLICATION
BLA761137
TYPE
BLA
ORIGINAL APPROVAL
2019-12-18
LATEST ACTION
2026-07-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PADCEVPrescription
ENFORTUMAB VEDOTIN-EJFV 20MG/VIAL · INJECTABLE · INJECTION
PADCEVPrescription
ENFORTUMAB VEDOTIN-EJFV 30MG/VIAL · INJECTABLE · INJECTION

Approval history

2026-07-10Efficacy · Supplement 37 · priority — Letter ↗AP
2025-11-21Efficacy · Supplement 32 · priority — Letter ↗AP
2025-02-27Labeling · Supplement 29 · standard — Letter ↗AP
2023-12-15Efficacy · Supplement 24 · priority — Label ↗AP
2023-12-15Efficacy · Supplement 25 · priority — Label ↗AP
2023-04-18Labeling · Supplement 19 · standard — Letter ↗AP
2023-04-03Efficacy · Supplement 18 · priority — Patient Information Sheet ↗AP
2023-04-03Labeling · Supplement 20 · standard — Letter ↗AP
2022-10-28Labeling · Supplement 17 · standard — Letter ↗AP
2021-07-09Efficacy · Supplement 8 · priority — Label ↗AP
2021-07-09Efficacy · Supplement 6 · priority — Label ↗AP
2021-03-22Labeling · Supplement 7 · standard — Label ↗AP
2019-12-18Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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