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Orally Disintegrating Desloratadine Approved

KENILWORTH, N.J., July 15 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE:SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved re-formulated CLARINEX(R) (desloratadine 2.5 mg and 5 mg) REDITABS(R) tablets for the treatment of allergy symptoms caused by both perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria (CIU), or hives of unknown cause, in adults and children 6 years of age and older. The tablet disintegrates orally, is taken once-daily for 24-hour relief, and now comes in a new "tutti frutti" flavor. This convenient new formulation will be available in both a 2.5 mg and a 5 mg dose, and will be in pharmacies nationwide in September 2005.

"The CLARINEX REDITABS formulation offers my patients a new, convenient treatment option for their allergies," said William Berger, M.D., a clinical professor in the Division of Allergy and Immunology at the University of California, Irvine. "An orally disintegrating tablet allows my patients the convenience to take their medication anytime and wherever they are even without water, and the once-daily dose helps them start each day with their symptoms under control."

The tablet dissolves rapidly allowing allergy sufferers to take their medication when it is convenient for them, even when they do not have access to water. Patients who have active lifestyles or dislike swallowing pills may prefer REDITABS for their allergy treatment. Options like REDITABS, make it possible to identify the most appropriate allergy treatment for each patient given their lifestyle and preferences.

"This new formulation, along with the currently available CLARINEX family of products, helps physicians tailor the treatment regimen to patients' specific needs and allows them to provide a variety of safe and effective allergy treatments for both children and adults," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough.

CLARINEX is the only prescription nonsedating antihistamine approved for patients as young as 6 months old and is available in different forms to accommodate patient preference and symptoms. The CLARINEX family of products includes CLARINEX (0.5 mg per 1 mL) Syrup for children as young as 6 months old, CLARINEX REDITABS for both adults and children starting at 6 years of age and CLARINEX (5 mg) Tablets and CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/pseudoephedrine 240 mg) Extended Release Tablets for patients 12 years of age and older. CLARINEX-D 24 HOUR combines an antihistamine with a decongestant for patients suffering from nasal congestion associated with seasonal allergic rhinitis.

CLARINEX also is the only prescription nonsedating, 24-hour antihistamine approved for the treatment of indoor and outdoor allergies and hives of unknown cause. The efficacy and safety of CLARINEX in outdoor allergies has been established in four double-blind, randomized, placebo-controlled studies involving more than 2,300 patients with seasonal allergies. CLARINEX was also studied in indoor allergies in two double-blind, randomized, placebo-controlled studies involving more than 1,300 patients with perennial allergies. A single 5 mg dose of CLARINEX taken once daily provides 24-hour nonsedating relief from nasal and non-nasal symptoms of indoor and outdoor allergies. The approval for CLARINEX in chronic idiopathic urticaria (CIU) was based on two double-blind, randomized, placebo-controlled studies involving more than 400 patients.

In clinical trials, CLARINEX provided significantly greater symptom relief than placebo. Also, CLARINEX provided powerful morning symptom relief with significant improvement in morning symptom scores over placebo.(1) The most common side effects in allergic rhinitis were sore throat, dry mouth and fatigue, with an incidence rate similar to placebo. In CIU studies, the most common side effects were headache, nausea and fatigue.

About Allergies and Hives
Seasonal allergies affect an estimated 36 million people in the U.S.2 Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

Chronic idiopathic urticaria (CIU) refers to ongoing outbreaks of hives that last longer than six weeks, with no known cause. They can develop anywhere on the body and are usually associated with itching. The itchy, red spots appear quickly and usually disappear within 24 hours and may reappear elsewhere on the body.(2)

Source: Schering-Plough Corporation

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