Manages cystic fibrosis. ANDA 91589, held by Teva Pharms USA. Tobramycin.
As of Nov 15, 2026, ANDA 91589 (Tobramycin), held by Teva Pharms USA, was first approved by FDA on Oct 10, 2013, with 6 approved supplements and 0 published complete response letters.
Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV 1 ) <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Rx |
| Jan 29, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 6, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 6, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 12, 2016 | Supplement 6Manufacturing | Approved | None posted |
| Oct 12, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 1, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 10, 2013 | Original application | 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
