FDA committee votes against approving Linhaliq for bronchiectasis.
A committee of experts from the FDA has voted against approving Linhaliq (inhaled ciprofloxacin), from Aradigm Corp, for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections. The panel voted 12 to 3 against Aradigm, clearly feeling that it has failed to provide convincing evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in those with chronic lung infections. This is mostly down to differences in the results from two clinical trials. The drug has a PDUFA date of Jan. 26.
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