FDA — authorised 6 November 2012
- Application: NDA203214
- Marketing authorisation holder: PF PRISM CV
- Local brand name: XELJANZ
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tofacitinib tablet in United States
FDA authorised Tofacitinib tablet on 6 November 2012
Marketing authorisations
FDA — authorised 25 September 2020
- Application: NDA213082
- Marketing authorisation holder: PFIZER
- Local brand name: XELJANZ
- Indication: SOLUTION — ORAL
- Status: approved
Tofacitinib tablet 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 Tofacitinib tablet approved in United States?
Yes. FDA authorised it on 6 November 2012; FDA authorised it on 25 September 2020.
Who is the marketing authorisation holder for Tofacitinib tablet in United States?
PF PRISM CV holds the US marketing authorisation.