Manages cystic fibrosis. ANDA 210871, held by Luoxin Aurovitas. Tobramycin.
As of Nov 15, 2026, ANDA 210871 (Tobramycin), held by Luoxin Aurovitas, was first approved by FDA on Jan 22, 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 |
|---|---|---|---|
| Jan 22, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tobramycin300MG/5ML · solution;inhalation | Tobramycin | Discontinued |
| Jul 21, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 22, 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
