FDA — authorised 2 July 2015
- Application: NDA206038
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: ORKAMBI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ivacaftor+lumacaftor in United States
FDA authorised Ivacaftor+lumacaftor on 2 July 2015
Marketing authorisations
FDA — authorised 7 August 2018
- Application: NDA211358
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: ORKAMBI
- Indication: GRANULE — ORAL
- Status: approved
Ivacaftor+lumacaftor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Ivacaftor+lumacaftor approved in United States?
Yes. FDA authorised it on 2 July 2015; FDA authorised it on 7 August 2018.
Who is the marketing authorisation holder for Ivacaftor+lumacaftor in United States?
VERTEX PHARMS INC holds the US marketing authorisation.