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www.fdanews.com/articles/61273-gsk-files-in-u-s-europe-for-rhinitis-drug

GSK FILES IN U.S., EUROPE FOR RHINITIS DRUG

July 28, 2006

GlaxoSmithKline (GSK) has submitted applications for both U.S. and European marketing approval for a new medicine to treat the symptoms of seasonal allergic rhinitis and perennial allergic rhinitis. The medicine, fluticasone furoate, is an enhanced-affinity intranasal corticosteroid with the proposed names of Allermist in the U.S. and Avamys in Europe.

The efficacy and safety of the drug have been evaluated in seven clinical trials with 2,555 adult and pediatric patients 2 and older. Patients taking the medicine reported significant improvements in a range of nasal symptoms compared with those taking a placebo.