Manages cystic fibrosis. ANDA 212848, held by Alkem Labs Ltd. Tobramycin.
As of Nov 15, 2026, ANDA 212848 (Tobramycin), held by Alkem Labs Ltd, was first approved by FDA on Apr 1, 2021, with 1 approved supplement 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 |
|---|---|---|---|
| Apr 1, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Rx |
| Jul 21, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 1, 2021 | 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
