FDA — authorised 28 November 2018
- Marketing authorisation holder: ASTELLAS
- Status: approved
🇺🇸 Xospata in United States
FDA authorised Xospata on 28 November 2018
Marketing authorisations
FDA — authorised 28 November 2018
- Application: NDA211349
- Marketing authorisation holder: ASTELLAS
- Local brand name: XOSPATA
- Indication: TABLET — ORAL
- Status: approved
Xospata 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 Xospata approved in United States?
Yes. FDA authorised it on 28 November 2018; FDA authorised it on 28 November 2018.
Who is the marketing authorisation holder for Xospata in United States?
ASTELLAS holds the US marketing authorisation.