FDA Questions Efficacy Of Novartis Inhaled CF Treatment

Law360, Washington (August 31, 2012, 3:39 PM EDT) -- U.S. Food and Drug Administration staffers have questioned whether Novartis AG's inhaled powder form of a cystic fibrosis treatment is effective enough to warrant agency approval, according to documents posted to the agency's website Friday.

In background documents for Wednesday's anti-infective drug advisory committee meeting, staffers expressed concerns that clinical trial data for Novartis' powder formulation of tobramycin — which is used to treat Pseudomonas aeruginosa in cystic fibrosis patients — wasn't robust enough.

Novartis has already had intravenous and inhaled solution versions of tobramycin approved...
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