Treats Mycobacterium avium complex (MAC) lung disease. NDA 207356, held by Insmed Inc. Amikacin Sulfate.
As of Nov 13, 2026, NDA 207356 (Arikayce Kit), held by Insmed Inc, was first approved by FDA on Sep 28, 2018, with 6 approved supplements and 0 published complete response letters.
LIMITED POPULATION: ARIKAYCE is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2020 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2018 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arikayce KitEQ 590MG BASE/8.4ML · suspension, liposomal;inhalation | Amikacin Sulfate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2026 | Supplement 25Labeling · Standard review | Approved | |
| Dec 5, 2025 | Supplement 19Labeling · Standard review | Approved | |
| Jun 1, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Feb 10, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Oct 19, 2020 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 13, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Sep 28, 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
