FDA approves Novartis antibacterial treatment for cystic fibrosis

Drug maker announces approval of Tobi Podhaler

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

Novartis called the product the only FDA-approved dry-powder inhaled antibacterial for Pa in the United States, and the company said it shortened the time needed to administer the drug by 70% in clinical trials. In other treatments, tobramycin is administered using a nebulizer.

"This is good news for the CF community," Cystic Fibrosis Foundation president Robert Beall said. "Managing daily CF treatments is a challenge for people with CF."

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