Bayer HealthCare Pharmaceuticals (BAY) Receives FDA Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler
Bayer HealthCare Pharmaceuticals (NYSE: BAY) announced that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency. Ciprofloxacin DPI is an investigational drug–device combination that combines ciprofloxacin dry powder formulated using Novartis' Proprietary PulmoSphere® technology with a delivery inhaler. Ciprofloxacin DPI is in Phase II development and is being studied for its safety and potential to improve lung function, as measured by the forced expiratory volume in 1 second (FEV1), in patients with CF.
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