Treats cystic fibrosis (CF). NDA 211358, held by Vertex Pharms Inc. Ivacaftor; Lumacaftor.
As of Nov 13, 2026, NDA 211358 (Orkambi), held by Vertex Pharms Inc, was first approved by FDA on Aug 7, 2018, with 5 approved supplements and 0 published complete response letters.
ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2024 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Sep 2, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2018 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Orkambi125MG/PACKET;100MG/PACKET · granule;oral | Ivacaftor; Lumacaftor | RxReference drug |
| Orkambi188MG/PACKET;150MG/PACKET · granule;oral | Ivacaftor; Lumacaftor | RxReference drug |
| Orkambi94MG/PACKET;75MG/PACKET · granule;oral | Ivacaftor; Lumacaftor | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Sep 25, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Dec 13, 2024 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Aug 3, 2023 | Supplement 5Labeling · Standard review | Approved | |
| Sep 2, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2018 | 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
