FDA
- Status: approved
🇺🇸 Xtandi in United States
Xtandi (xtandi) regulatory status in United States.
Marketing authorisations
FDA
- Status: approved
Xtandi 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 Xtandi approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Xtandi in United States?
Astellas Pharma is the originator. The local marketing authorisation holder may differ — check the official source linked above.