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In Brief: Rorer's Nasacort AQ Nasal Spray

This article was originally published in The Tan Sheet

Executive Summary

Rorer's Nasacort AQ Nasal Spray: Rhone-Poulenc Rorer submits sNDA for approval of product's benefits to "children as young as four," RPR announced Oct. 22. Submission contains results from two double-blind, placebo-controlled trials involving 538 children with seasonal or perennial allergic rhinitis. At doses of 110 mcg or 220 mcg once daily, Nasacort AQ was found to effect "statistically significant reductions of allergic rhinitis symptoms." Pharyngitis, fever, rhinitis, and flu symptoms were the most commonly reported adverse events. Should Nasacort switch to OTC, Ciba would gain rights to its marketing per the companies' December 1994 agreement ("The Tan Sheet" Jan. 2, 1995, p. 4)...

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