FDA — authorised 25 March 2020
- Application: NDA209899
- Marketing authorisation holder: BRISTOL
- Local brand name: ZEPOSIA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Zeposia in United States
FDA authorised Zeposia on 25 March 2020
Marketing authorisations
FDA
- Status: approved
Zeposia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Zeposia approved in United States?
Yes. FDA authorised it on 25 March 2020; FDA has authorised it.
Who is the marketing authorisation holder for Zeposia in United States?
BRISTOL holds the US marketing authorisation.