Sunday, June 12, 2011

FDA Accepts Filing Of New Drug Application For Nycomed's Ciclesonide HFA Nasal Aerosol

Nycomed's licensing partner Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation. The proposed dosing for ciclesonide HFA nasal aerosol is 74 mcg once-daily (37 mcg per spray; one-spray per nostril) and the proposed indication is for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) and Perennial Allergic Rhinitis (PAR), in adults and adolescents age 12 and older...

doctor oz

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