FDA — authorised 6 November 2012
- Application: NDA203214
- Marketing authorisation holder: PF PRISM CV
- Local brand name: XELJANZ
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Xeljanz in United States
FDA authorised Xeljanz 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
FDA — authorised 13 March 2023
- Application: ANDA209738
- Marketing authorisation holder: MICRO LABS
- Local brand name: TOFACITINIB CITRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2023
- Application: ANDA216878
- Marketing authorisation holder: HIKMA
- Local brand name: TOFACITINIB CITRATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 December 2024
- Application: ANDA218668
- Marketing authorisation holder: DEXCEL
- Local brand name: TOFACITINIB CITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 September 2025
- Application: ANDA216001
- Marketing authorisation holder: SINOTHERAPEUTICS INC
- Local brand name: TOFACITINIB CITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 November 2025
- Application: ANDA219442
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: TOFACITINIB CITRATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
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.
Frequently asked questions
Is Xeljanz approved in United States?
Yes. FDA authorised it on 6 November 2012; FDA authorised it on 25 September 2020; FDA authorised it on 13 March 2023.
Who is the marketing authorisation holder for Xeljanz in United States?
PF PRISM CV holds the US marketing authorisation.