Bayer’s Cipro CF Drug Gets Orphan Designation

Bayer HealthCare Pharmaceuticals was granted an orphan drug designation by the FDA for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Bayer HealthCare Pharmaceuticals was granted an orphan drug designation by the FDA for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. Ciprofloxacin DPI is an investigational drug–device combination that combines ciprofloxacin dry powder formulated using Novartis’ PulmoSphere technology with a delivery inhaler. Ciprofloxacin DPI is in Phase II development and is being studied for its safety and pot...

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