FDA — authorised 31 January 2012
- Application: NDA203188
- Marketing authorisation holder: VERTEX PHARMS
- Status: supplemented
🇺🇸 Kalydeco in United States
FDA authorised Kalydeco on 31 January 2012
Marketing authorisations
FDA — authorised 17 March 2015
- Application: NDA207925
- Marketing authorisation holder: VERTEX PHARMS INC
- Status: supplemented
FDA
- Status: approved
Other Respiratory approved in United States
Frequently asked questions
Is Kalydeco approved in United States?
Yes. FDA authorised it on 31 January 2012; FDA authorised it on 17 March 2015; FDA has authorised it.
Who is the marketing authorisation holder for Kalydeco in United States?
VERTEX PHARMS holds the US marketing authorisation.