FDA — authorised 9 September 2022
- Marketing authorisation holder: BRISTOL-MYERS SQUIBB
- Status: approved
🇺🇸 Sotyktu in United States
FDA authorised Sotyktu on 9 September 2022
Marketing authorisations
FDA — authorised 9 September 2022
- Application: NDA214958
- Marketing authorisation holder: BRISTOL
- Local brand name: SOTYKTU
- Indication: TABLET — ORAL
- Status: approved
Sotyktu 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 Sotyktu approved in United States?
Yes. FDA authorised it on 9 September 2022; FDA authorised it on 9 September 2022.
Who is the marketing authorisation holder for Sotyktu in United States?
BRISTOL-MYERS SQUIBB holds the US marketing authorisation.