FDA — authorised 22 August 2017
- Application: NDA203214
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
🇺🇸 Xeljanz in United States
FDA authorised Xeljanz on 22 August 2017
Marketing authorisations
FDA — authorised 18 October 2018
- Application: NDA208246
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
FDA — authorised 2 December 2021
- Application: NDA213082
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
Xeljanz 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 Xeljanz approved in United States?
Yes. FDA authorised it on 22 August 2017; FDA authorised it on 18 October 2018; FDA authorised it on 2 December 2021.
Who is the marketing authorisation holder for Xeljanz in United States?
PF PRISM CV holds the US marketing authorisation.