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Antimicrobial Drugs Advisory Committee

On Thursday, November 16, 2017 the Antimicrobial Drugs Advisory Committee (AMDAC) supported/did not support, by a vote of 6-Yes to 9-No, with no abstentions the safety and efficacy of the proposed 14-day regimen of ciprofloxacin dry powder inhaler (DPI), sponsored by Bayer HealthCare Pharmaceuticals, Inc. (Bayer), for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients with respiratory bacterial pathogens. The Committee did not support, by a vote of 1-Yes to 14-No, with no abstentions the proposed 28-day regimen.