FDA approves Clarinex-D® 12 Hour

Journal of Drugs in Dermatology, April, 2006 by Monika Srivastava

The FDA recently approved Clarinex-D 12 Hour (deslorati-dine 2.5 mg and pseudoephedrine sulfate, USP 120 mg) Extended Release Tablets for the treatment of seasonal allergic rhinitis, including nasal congestion, in patients aged 12 years or older. Unlike other allergy medications Clarinex-D 12 Hour was formulated to provide relief from nasal blockage without drowsiness. The tablet uses a bi-layer delivery system which allows for consistent release of pseudoephedrine throughout the day.

FDA approval of Clarinex-D 12 Hour Extended Release Tablets was based on results from 2 clinical studies enrolling 1,248 patients aged 12 to 78 suffering from seasonal allergic rhinitis. Both 2-week randomized, parallel group trials demonstrated significantly greater efficacy of Clarinex-D 12 hour compared to pseudoephedrine alone and desloratidine alone in controlling allergic rhinitis symptoms including nasal congestion. Clarinex-D 12 Hour Extended Release Tablets will be available to patients in the US by prescription in March 2006.