Novartis’ TOBI Podhaler Wins Advisory Panel Backing, Boosted By Experience With Current Version
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s Anti-Infective Drugs Advisory Committee voted 13-1 Sept. 5 that the new powder formulation of tobramycin administered with a newly designed inhaler is safe and effective for managing cystic fibrosis patients infected with Pseudomonas aeruginosa, despite the agency’s qualms about the clinical trial data.