Treats cystic fibrosis (CF). NDA 210491, held by Vertex Pharms Inc. Ivacaftor; Ivacaftor, Tezacaftor.
As of Nov 13, 2026, NDA 210491 (Symdeko (Copackaged)), held by Vertex Pharms Inc, was first approved by FDA on Feb 12, 2018, with 6 approved supplements and 0 published complete response letters.
SYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2020 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jun 21, 2019 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 12, 2018 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Symdeko (Copackaged)150MG;150MG, 100MG · tablet;oral | Ivacaftor; Ivacaftor, Tezacaftor | RxReference drug |
| Symdeko (Copackaged)75MG;75MG, 50MG · tablet;oral | Ivacaftor; Ivacaftor, Tezacaftor | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2026 | Supplement 14Labeling | Approved | |
| Sep 25, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Aug 3, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Dec 21, 2020 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Dec 27, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Jun 21, 2019 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 12, 2018 | Original applicationNew molecular entity, new combination · 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
