FDA — authorised 21 October 2019
- Application: NDA212273
- Marketing authorisation holder: VERTEX PHARMS INC
- Status: supplemented
🇺🇸 Trikafta in United States
FDA authorised Trikafta on 21 October 2019
Marketing authorisations
FDA — authorised 26 April 2023
- Application: NDA217660
- Marketing authorisation holder: VERTEX PHARMS INC
- Status: supplemented
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Trikafta approved in United States?
Yes. FDA authorised it on 21 October 2019; FDA authorised it on 26 April 2023; FDA has authorised it.
Who is the marketing authorisation holder for Trikafta in United States?
VERTEX PHARMS INC holds the US marketing authorisation.