FDA — authorised 26 April 2024
- Application: NDA218347
- Marketing authorisation holder: ABBVIE
- Local brand name: RINVOQ LQ
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 JAKi in United States
FDA authorised JAKi on 26 April 2024
Marketing authorisations
FDA
- Application: ANDA218792
- Marketing authorisation holder: SANDOZ INC
- Local brand name: UPADACITINIB
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA218866
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: UPADACITINIB
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is JAKi approved in United States?
Yes. FDA authorised it on 26 April 2024; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for JAKi in United States?
ABBVIE holds the US marketing authorisation.