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News From the Food and Drug Administration
March 4, 1998

Tobramycin Inhalation Product Approved for Use in Cystic Fibrosis Therapy

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JAMA. 1998;279(9):645. doi:10.1001/jama.279.9.645-JFD80000-2-1

The FDA has approved a tobramycin solution product for inhalation (TOBI, PathoGenesis Corporation, Seattle, Wash) for use in the treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis who are at least 6 years of age. Two double-blind, randomized, placebo-controlled, 24-week clinical studies demonstrated effectiveness of tobramycin as administered in the new formulation. A total of 258 treated patients showed significant improvement in pulmonary function and significant decrease in the number of hospitalized days compared with placebo controls. In 1 study, percent predicted FEV1 (forced expiratory volume in 1 second) increased relatively about 7% on average among treated patients compared with an average decrease of 1% among patients in the placebo group. TOBI was administered twice a day in a regimen of 28 days on and 28 days off the drug.