FDA Approves New Powder Form of CF Drug TOBI®

The U.S. Food and Drug Administration (FDA) has approved TOBI® Podhaler™ (tobramycin inhalation powder), a dry powder formulation of the antibiotic TOBI, to treat lung infections caused by the bacteria Pseudomonas aeruginosa (P. aeruginosa).

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The FDA approved the new treatment for people with CF ages 6 and older who have P. aeruginosa and whose lung function (FEV1) is between 25 percent and 80 percent predicted.

According to the drug's manufacturer, Novartis, TOBI Podhaler shortens treatment time by about 70 percent, compared with nebulized TOBI.

TOBI Podhaler is administered with a pocket-sized inhaler, and does not require a nebulizer. TOBI Podhaler does not need to be stored in a refrigerator and does not require a power source to operate the inhaler.

Novartis said it anticipates TOBI Podhaler will be available in the United States in the second quarter of 2013.

P. aeruginosa is found in about half of all people with CF in the U.S. and is the leading cause of lung damage in those living with the disease.

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