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FDA Approves Clarinex (Desloratadine) Syrup for Relief of Symptoms Associated With Indoor and Outdoor Allergies and Hives in Children
-- Indoor Allergies and Hives for Children Six Months and Older -- Outdoor Allergies for Children Two Years and Older
KENILWORTH, NJ -- September 2, 2004 -- Schering-Plough Corporation (NYSE: SGP) announced that the U.S. Food and Drug Administration (FDA) has approved the use of Clarinex® (desloratadine) Syrup for the relief of symptoms associated with seasonal allergic rhinitis (SAR) (outdoor allergies) in children two years and older and perennial allergic rhinitis (PAR) (indoor allergies) and chronic idiopathic urticaria (CIU), or hives of unknown cause in children as young as six months. The approval of the CIU and PAR indications makes it the only prescription non-sedating antihistamine syrup on the market for a patient population as young as six months. The new Clarinex Syrup is expected to be available in the U.S. during the first half of 2005.
Clinical Trials
The FDA approval of the new Clarinex Syrup results from three double- blind, placebo-controlled safety studies involving 246 pediatric subjects six months to 11 years of age with a documented history of allergic rhinitis, chronic idiopathic urticaria, or subjects who were candidates for antihistamine therapy. The results of these studies demonstrated the safety of Clarinex Syrup in pediatric subjects six months to 11 years of age.
In clinical trials, the overall incidence of adverse events in children six years through 11 years of age was similar for the desloratadine syrup and the placebo groups. In pediatric patients six months to five years of age, the most frequently seen adverse events were upper respiratory tract infection, diarrhea, fever, urinary tract infection, varicella, irritability and coughing. Full prescribing information is available at: http://www.spfiles.com/piclarinex.pdf.
SOURCE: Schering-Plough Corporation
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