FDA — authorised 2 July 2015
- Application: NDA206038
- Marketing authorisation holder: VERTEX PHARMS INC
- Status: supplemented
🇺🇸 Orkambi in United States
FDA authorised Orkambi on 2 July 2015
Marketing authorisations
FDA — authorised 7 August 2018
- Application: NDA211358
- Marketing authorisation holder: VERTEX PHARMS INC
- Status: supplemented
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Orkambi approved in United States?
Yes. FDA authorised it on 2 July 2015; FDA authorised it on 7 August 2018; FDA has authorised it.
Who is the marketing authorisation holder for Orkambi in United States?
VERTEX PHARMS INC holds the US marketing authorisation.