RecallHawk

PADCEV EJFV (ENFORTUMAB VEDOTIN)

ASTELLAS

Summary

FDA approved PADCEV EJFV (ENFORTUMAB VEDOTIN) by ASTELLAS. BLA (Biologic) approval (Efficacy) on 2025-11-21. INJECTABLE, INJECTION.

Details

Source

Drug Approval

External ID

BLA761137-32

Action Date

2025-11-21

Status

Approved

Category

drug

Product Code

BLA (Biologic)

Product Description

PADCEV EJFV (generic: ENFORTUMAB VEDOTIN), INJECTABLE, INJECTION. Application: BLA761137

Company

Context & Analysis

ASTELLAS has 6 FDA actions in our database.

Frequently Asked Questions

How often does ASTELLAS have FDA actions?

ASTELLAS has 6 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "BLA761137-32" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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