Manages cystic fibrosis. NDA 205433, held by Pulmoflow Inc. Tobramycin.
As of Nov 13, 2026, NDA 205433 (Kitabis Pak), held by Pulmoflow Inc, was first approved by FDA on Dec 2, 2014, with 4 approved supplements and 0 published complete response letters.
KITABIS PAK (co-packaging of tobramycin inhalation solution and PARI LC PLUS Reusable Nebulizer) is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV 1 < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 2, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Kitabis Pak300MG/5ML · solution;inhalation | Tobramycin | Rx |
| Apr 10, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Feb 10, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Dec 6, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Nov 18, 2016 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 2, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
