FDA — authorised 18 December 2019
- Application: BLA761137
- Marketing authorisation holder: ASTELLAS
- Local brand name: PADCEV
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 enfortumab vedotin (EV) in United States
FDA authorised enfortumab vedotin (EV) on 18 December 2019
Marketing authorisation
enfortumab vedotin (EV) 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 enfortumab vedotin (EV) approved in United States?
Yes. FDA authorised it on 18 December 2019.
Who is the marketing authorisation holder for enfortumab vedotin (EV) in United States?
ASTELLAS holds the US marketing authorisation.