FDA — authorised 25 March 2020
- Marketing authorisation holder: CELGENE INTL
- Status: approved
🇺🇸 Zeposia in United States
FDA authorised Zeposia on 25 March 2020
Marketing authorisations
FDA — authorised 27 May 2021
- Application: NDA209899
- Marketing authorisation holder: BRISTOL
- Indication: Efficacy
- 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 Immunology approved in United States
Frequently asked questions
Is Zeposia approved in United States?
Yes. FDA authorised it on 25 March 2020; FDA authorised it on 27 May 2021.
Who is the marketing authorisation holder for Zeposia in United States?
CELGENE INTL holds the US marketing authorisation.