Treats cystic fibrosis (CF). NDA 207925, held by Vertex Pharms Inc. Ivacaftor.
As of Nov 13, 2026, NDA 207925 (Kalydeco), held by Vertex Pharms Inc, was first approved by FDA on Mar 17, 2015, with 13 approved supplements and 0 published complete response letters.
KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
| May 22, 2025 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| May 3, 2023 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Dec 21, 2020 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 2020 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Apr 29, 2019 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Aug 15, 2018 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jul 31, 2017 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| May 17, 2017 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 8, 2017 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 17, 2015 | Original applicationNew dosage form · Priority review | Approved |
| Mar 17, 2026 | Supplement 21Labeling | Approved | |
| Sep 25, 2025 | Supplement 20Labeling · Standard review | Approved | |
| May 22, 2025 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Aug 3, 2023 | Supplement 17Labeling · Standard review | Approved | |
| May 3, 2023 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Dec 21, 2020 | Supplement 13Efficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 2020 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Apr 29, 2019 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Aug 15, 2018 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jul 31, 2017 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| May 17, 2017 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Feb 8, 2017 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 8, 2016 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 17, 2015 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
