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FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
Date:3/11/2010

(6)  Cystic Fibrosis Foundation: Cystic Fibrosis Foundation Patient Registry, 2008 Annual Data Report. Cystic Fibrosis Foundation. Bethesda, MD.

(7)  Kosorok MR, et al. (2001): Acceleration of lung disease in children with cystic fibrosis after Pseudomonas aeruginosa acquisition. Pediatr Pulmonol, 32, 277-287

(8)  Emerson J, et al. (2002): Pseudomonas aeruginosa and other predictors of mortality and morbidity in young children with cystic fibrosis. Pediatr Pulmonol, 34, 91-100

(9)  Data on file – MRR Study 1270

(10)  Stass H, et al. (2008): Pharmacokinetics of inhaled ciprofloxacin powder. Poster presented at the 31st European Cystic Fibrosis Conference, Prague, Czech Republic, 11-14 June 2008

(11)  Stass H, et al. (2008): Ciprofloxacin PulmoSphere® inhalation pow
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