Sanofi-Aventis Wins FDA Approval for Nasacort AQ Nasal Spray
Posted on: Wednesday, 24 September 2008, 12:00 CDT
Sanofi-Aventis has announced that the FDA has approved Nasacort AQ nasal spray for children aged two to five years old for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.
The FDA based its approval on the results of a multicenter, randomized, double-blind, placebo-controlled study demonstrating that Nasacort AQ can be used safely and effectively to treat nasal symptoms of year-round allergies in children between two and five years.
This is said to be the first and largest placebo-controlled trial designed to specifically investigate both the efficacy and safety of an intranasal corticosteroid versus placebo in two to five years of age group.
Steven Weinstein, director of allergy and asthma specialist medical group in Huntington Beach, California, said: "We welcome this new treatment option for our very young patients. Nasacort AQ nasal spray has been proven effective for the age groups two to five years to relieve nasal allergy symptoms."
Source: Datamonitor
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