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FDA Approval of Clarinex (Desloratadine) for Treatment of Seasonal Allergic Rhinitis MARLBOROUGH, MA -- December 24, 2001 -- Sepracor Inc.reported that Schering-Plough Corporation (NYSE: SGP) announced that Clarinex® (desloratadine) 5 mg Tablets has received marketing clearance from the U.S. Food and Drug Administration (FDA) for the treatment of seasonal allergic rhinitis (SAR) in adults and children 12 years of age and older. Clarinex is a new antihistamine that is said by Schering-Plough to provide 24-hour relief from the symptoms of SAR. An H-1 receptor antagonist, Clarinex Tablets taken once daily in clinical trials significantly reduced total symptom scores of the nasal and non-nasal symptoms of seasonal allergies. Schering-Plough expects Clarinex launch activities to begin in January 2002. In December 1997, Schering-Plough Corporation and Sepracor announced a licensing agreement giving Schering-Plough exclusive worldwide rights to Sepracor's patents relating to desloratadine. Sepracor will receive royalties upon launch of Clarinex in the U.S. Schering-Plough has received an "approvable letter" from the FDA for Clarinex Tablets for the treatment of chronic idiopathic urticaria (CIU), or hives of unknown cause. A separate new drug application (NDA) is also pending for the treatment of allergic rhinitis (AR), which encompasses both SAR and perennial allergic rhinitis (PAR). Allergies affect an estimated 45 million Americans and can have a significant impact on everyday activities at work, school and leisure time. The direct cost of seasonal allergies, including medications and physician visits, has been estimated at US$4.5 billion annually. Indirect costs from absenteeism include the loss of an estimated six million workdays and two million school days each year. In addition, there is a growing body of evidence that points to an association between allergies and even more serious conditions, such as asthma. SOURCE Sepracor Inc. E-mail this page to a friend or colleague! To print, use this version