Reuters: Regulatory News: U.S. FDA panel backs Novartis cystic fibrosis drug

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U.S. FDA panel backs Novartis cystic fibrosis drug Sep 5th 2012, 19:53 WASHINGTON, Sept 5 | Wed Sep 5, 2012 3:53pm EDT WASHINGTON, Sept 5 (Reuters) - U.S. drug advisers on Wednesday backed a novel form of Novartis AG's inhaled antibiotic that treats a lung infection linked to cystic fibrosis. A panel of outside advisers to the U.S. Food and Drug Administration voted 13 to 1 that Novartis had demonstrated that its tobramycin inhalation powder, or TIP, was safe and effective. The FDA usually follows panel recommendations, although it is not required to do so and will make a final decision later. Novartis is seeking approval of the inhaled antibiotic powder as a more convenient alternative to its older, nebulized version of tobramycin, called Tobi.

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