FDA — authorised 26 June 2023
- Application: BLA761286
- Marketing authorisation holder: UCB INC
- Local brand name: RYSTIGGO
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 RYSTIGGO in United States
FDA authorised RYSTIGGO on 26 June 2023
Marketing authorisations
FDA
- Status: approved
RYSTIGGO in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is RYSTIGGO approved in United States?
Yes. FDA authorised it on 26 June 2023; FDA has authorised it.
Who is the marketing authorisation holder for RYSTIGGO in United States?
UCB INC holds the US marketing authorisation.