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Pharmaceuticals / Submissions and Approvals

Advisory Committee Votes Against Bayer’s Cipro Inhalation Powder

Nov. 21, 2017

An FDA advisory committee voted to not recommend two regimens for Bayer’s inhalation-powder formulation of ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis, citing inconsistent data from clinical trials.

The Antimicrobial Drugs Advisory Committee voted 9-to-6 against recommending a 14-day regimen and 14-to-1 against a 28-day regimen.

FDA representatives noted that while clinical trial findings generally indicated ciprofloxacin’s benefits, they lacked consistency among common endpoints between trials and among related endpoints within the same trial, as well as between the 28-day and 14-day regimens in the same trial.

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