FDA Advisory Panel Unanimously Votes Down Pharmaxis’ Bronchitol

The FDA’s Pulmonary-Allergy Drugs Advisory Committee unanimously voted against recommending Pharmaxis’ cystic fibrosis (CF) drug Bronchitol for approval. While committee members were concerned the Bronchitol (dry powder mannitol) was not proven safe and effective in children, most said they would have voted in favor of approval if the indication was only for adults.
Drug Industry Daily