Adcom Tips Its Hat to New Novartis CF Formulation

While having, in effect, only one controlled trial to support approval of Novartis AG's TOBI Podhaler (TIP) raised flags for FDA reviewers, it didn't faze the agency's Anti-Infective Drugs Advisory Committee.

Instead, the committee praised the Basel, Switzerland-based company for responding to the needs of the cystic fibrosis (CF) community and voted 13-1 that Novartis submitted adequate evidence of the product's safety and efficacy in managing Pseudomonas aeruginosa in CF patients.