Manages cystic fibrosis. ANDA 214478, held by Mankind Pharma. Tobramycin.
As of Nov 15, 2026, ANDA 214478 (Tobramycin), held by Mankind Pharma, was first approved by FDA on Jun 30, 2023, with 0 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 |
|---|---|---|---|
| Jun 30, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Rx |
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
