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Clarinex-D 24-hour approved

This article was originally published in The Tan Sheet

Executive Summary

FDA clears the Rx desloratadine 5 mg/pseudoephedrine sulfate 240 mg combination "for relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older," Schering-Plough announces March 4. The agency approved the extension following review of two randomized, parallel group clinical trials evaluating 2,852 subjects ages 12 to 78 over two weeks; 708 participants received Clarinex-D. "In both trials, the antihistaminic efficacy of Clarinex-D 24-Hour, when examining symptoms of allergic rhinitis excluding nasal congestion, was significantly greater than pseudoephedrine or Claritin 5 mg alone," Schering says. Availability of the non-sedating antihistamine tablets will coincide with the spring allergy season...





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