General MedicationsINJECTIONStandard
PADCEV
ENFORTUMAB VEDOTIN-EJFV
Standard Dose
20MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview PADCEV is listed in Drugs@FDA under application 761137 (BLA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient ENFORTUMAB VEDOTIN-EJFV Form and strength INJECTABLE;INJECTION - 20MG/VIAL Sponsor ASTELLAS Submission history Latest submission status date: 2025-11-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview PADCEV is listed in Drugs@FDA under application 761137 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ENFORTUMAB VEDOTIN-EJFV Form and strength INJECTABLE;INJECTION - 20MG/VIAL Sponsor ASTELLAS Submission history Latest submission status date: 2025-11-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.