FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis

ENPNewswire-11 March 2010-FDA Grants Orphan Drug Status to Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis(C)2010 ENPublishing - http://www.enpublishing.co.uk Release date- 11032010 - Berlin - Bayer Schering Pharma AG, Germany, announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for the ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency (EMA). Ciprofloxacin DPI is an innovative drug-device combination. It combines ciprofloxacin dry powder that is formulated using Novartis' Proprietary PulmoSphere(R) technology with an innovative easy-to-use 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.