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Sep 10, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Tobramycin inhalation powder regulatory update

FDA's Anti-Infective Drugs Advisory Committee voted 13-1 that Novartis demonstrated adequate evidence of safety and evidence to support the use of tobramycin inhalation powder for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections. The inhaled, dry powder formulation of tobramycin is approved in the EU, Canada, Switzerland and Australia. Novartis markets a nebulizer formulation under the name TOBI tobramycin.

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