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FDA Questions Novartis AG (NVS) Cystic Fibrosis Drug


8/31/2012 8:13:58 AM

U.S. drug reviewers questioned whether Novartis AG's inhaled antibiotic treatment truly helped cystic fibrosis patients breathe better, according to documents posted online by the U.S. Food and Drug Administration on Friday. Staff from the FDA released their review of Novartis's tobramycin inhaled powder ahead of a vote next Wednesday by an advisory committee of outside experts on whether to recommend the drug. Novartis is seeking approval of the inhaled antibiotic powder as a more convenient alternative to its older, nebulized version of tobramycin called Tobi, saying a powder taken with an inhaler is faster to use, and more convenient for patients.

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