Panel backs tobramycin inhalation powder

FDA's Anti-Infective Drugs Advisory Committee voted 13-1 that Novartis AG (NYSE:NVS; SIX:NOVN) demonstrated adequate evidence of safety and evidence to support the use of tobramycin inhalation powder (formerly TOBI Podhaler) 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. ...