FDA — authorised 28 October 2022
- Application: BLA761137
- Marketing authorisation holder: ASTELLAS
- Indication: Labeling
- Status: approved
🇺🇸 Padcev Ejfv in United States
FDA authorised Padcev Ejfv on 28 October 2022
Marketing authorisation
Padcev Ejfv in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Padcev Ejfv approved in United States?
Yes. FDA authorised it on 28 October 2022.
Who is the marketing authorisation holder for Padcev Ejfv in United States?
ASTELLAS holds the US marketing authorisation.