Manages Pseudomonas aeruginosa. ANDA 216725, held by Mankind Pharma. Tobramycin.
As of Nov 15, 2026, ANDA 216725 (Tobramycin), held by Mankind Pharma, was first approved by FDA on Sep 22, 2022, with 1 approved supplement and 0 published complete response letters.
Tobramycin inhalation solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/4ML · solution;inhalation | Tobramycin | Rx |
| Jun 30, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 22, 2022 | Original application | Approved | None posted |
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
