FDA — authorised 23 February 2016
- Application: NDA208246
- Marketing authorisation holder: PFIZER
- Local brand name: XELJANZ XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Xeljanz in United States
FDA authorised Xeljanz on 23 February 2016
Marketing authorisations
FDA
- 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 23 February 2016; FDA has authorised it.
Who is the marketing authorisation holder for Xeljanz in United States?
PFIZER holds the US marketing authorisation.