Manages cystic fibrosis. ANDA 207080, held by Dr Reddys Labs SA. Tobramycin.
As of Nov 15, 2026, ANDA 207080 (Tobramycin), held by Dr Reddys Labs SA, was first approved by FDA on Jul 9, 2018, with 2 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 |
|---|---|---|---|
| Jul 9, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Rx |
| Jul 10, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 20, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 9, 2018 | 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
