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| |  CLARITIN Syrup, First Nondrowsy Antihistamine for Children Cleared by FDA MADISON, N.J., Oct. 14, 1996 -- Schering-Plough Corporation (NYSE: SGP) announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for CLARITIN(R) Syrup (loratadine) 10 mg per 10 mL, the first and only nondrowsy antihistamine syrup for children as young as 6 years. In addition, the indication for CLARITIN(R) (10 mg) tablets was expanded to include children age 6 and up. Available only by prescription in a once-daily formula, CLARITIN Syrup is indicated for the treatment of allergy symptoms, including itchy, watery eyes; runny nose; itchy palate; sneezing; and idiopathic chronic urticaria (commonly known as hives). CLARITIN Syrup is the newest member of the CLARITIN brand, the No. 1 antihistamine in the world. CLARITIN Syrup is available in 72 countries and has over 150 million patient days of use. "Prior to the launch of CLARITIN Syrup, all antihistamines for children -- over-the-counter and prescription -- carried the risk of causing drowsiness and hyperactivity," said Richard W. Zahn, president, Schering Laboratories, the U.S. prescription pharmaceutical marketing arm of Schering-Plough. "New CLARITIN Syrup allows us to broaden the U.S. allergy market by combining the CLARITIN brand's unique benefits and proven heritage in a convenient, effective formula to treat children's allergies without drowsy side effects." Studies show seasonal allergies can affect up to 42 percent of school-age children. On a typical school day, more than 10,000 children are absent due to seasonal allergies. In addition to symptoms such as nasal congestion; sneezing; itchy, watery eyes; and hives, children with allergies often suffer from emotional effects, including mood swings, irritability, temper tantrums and/or decreased ability to concentrate -- symptoms of a condition known as allergic irritability syndrome. Other potential consequences include low self-esteem and difficulty with peer interaction. "Children suffering from seasonal allergies are often misdiagnosed or mistreated for their symptoms because they are unable to communicate to their parents and doctors how they feel," said Philip Fireman, M.D., Professor of Pediatrics and Medicine, University of Pittsburgh School of Medicine, and Director of Allergy and Immunology, Children's Hospital of Pittsburgh. "With this new class of nonsedating antihistamines for children, CLARITIN Syrup will treat children's physical symptoms of seasonal allergic rhinitis without causing drowsiness or hyperactivity." CLARITIN Syrup, in an alcohol-free and dye-free fruit-flavored formula, is administered orally at a dose of two teaspoons once-per-day for children as young as 6 years of age. In controlled clinical trials using the recommended dose, the incidence of the most commonly reported adverse events was comparable to placebo. Since its U.S. introduction in 1993, the CLARITIN brand (CLARITIN and CLARITIN-D 12 Hour, and recently approved CLARITIN-D 24 Hour) has provided safe, effective and convenient relief for millions of individuals suffering from the symptoms of seasonal allergies. CLARITIN has more than 3 billion patient days of use and is the most prescribed antihistamine among U.S. allergists. CLARITIN is the only once-a-day nonsedating antihistamine without a black box warning for serious cardiovascular events. For allergy management and treatment information, consumers can call 1-800-CLARITIN. Schering-Plough manufactures and markets U.S. prescription pharmaceuticals through its Schering Laboratories, Key Pharmaceuticals and Warrick Pharmaceuticals units. Products include respiratory products, dermatologicals, anti-infectives, anticancer and antiviral products, and cardiovasculars. The company also manufactures and markets animal health products, leading over-the-counter (OTC) pharmaceuticals and personal care products. Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
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