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