FDA — authorised 31 January 2012
- Marketing authorisation holder: VERTEX PHARMS
- Status: approved
🇺🇸 Kalydeco in United States
FDA authorised Kalydeco on 31 January 2012
Marketing authorisations
FDA — authorised 31 January 2012
- Application: NDA203188
- Marketing authorisation holder: VERTEX PHARMS
- Local brand name: KALYDECO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2015
- Application: NDA207925
- Marketing authorisation holder: VERTEX PHARMS INC
- Local brand name: KALYDECO
- Indication: GRANULE — ORAL
- Status: approved
FDA — authorised 12 February 2018
- Application: NDA210491
- Marketing authorisation holder: VERTEX PHARMS INC
- Indication: Type 1 - New Molecular Entity and Type 4 - New Combination
- Status: approved
FDA — authorised 2 September 2022
- Application: NDA211358
- Marketing authorisation holder: VERTEX PHARMS INC
- Indication: Efficacy
- Status: approved
FDA — authorised 3 August 2023
- Application: NDA217660
- Marketing authorisation holder: VERTEX PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 25 September 2025
- Application: NDA212273
- Marketing authorisation holder: VERTEX PHARMS INC
- Indication: Labeling
- Status: approved
Vertex Pharms Inc received marketing authorisation from the FDA for Kalydeco on 25 September 2025. The application number for this approval is NDA212273. The indication approved for Kalydeco is listed in the labelling, but the specific indication is not reported in the available data.
FDA
- Application: ANDA216074
- Marketing authorisation holder: LUPIN LTD
- Local brand name: IVACAFTOR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA217431
- Marketing authorisation holder: LUPIN LTD
- Local brand name: IVACAFTOR
- Indication: GRANULE — ORAL
- Status: approved
Kalydeco 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 Kalydeco approved in United States?
Yes. FDA authorised it on 31 January 2012; FDA authorised it on 31 January 2012; FDA authorised it on 17 March 2015.
Who is the marketing authorisation holder for Kalydeco in United States?
VERTEX PHARMS holds the US marketing authorisation.