FDA — authorised 10 October 2019
- Marketing authorisation holder: VERTEX PHARMS INC
- Status: approved
🇺🇸 Trikafta (Copackaged) in United States
FDA authorised Trikafta (Copackaged) on 10 October 2019
Marketing authorisations
FDA — authorised 21 October 2019
- Application: NDA212273
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: TRIKAFTA (COPACKAGED)
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Trikafta (Copackaged) for the treatment of cystic fibrosis in patients aged 12 years and older. This approval was granted to Vertex Pharms Inc following a standard expedited pathway. The application number for this approval is NDA212273.
FDA — authorised 3 August 2023
- Application: NDA217660
- Marketing authorisation holder: VERTEX PHARMS INC
- Indication: Labeling
- Status: approved
Trikafta (Copackaged) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Trikafta (Copackaged) approved in United States?
Yes. FDA authorised it on 10 October 2019; FDA authorised it on 21 October 2019; FDA authorised it on 3 August 2023.
Who is the marketing authorisation holder for Trikafta (Copackaged) in United States?
VERTEX PHARMS INC holds the US marketing authorisation.