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| |  CLARITIN-D 24 Hour Antihistamine/Decongestant Cleared By FDA MADISON, N.J., Aug. 26, 1996-- Schering-Plough Corporation (NYSE: SGP), the leading allergy company in the United States, announced today that CLARITIN(R)-D 24 Hour Extended Release Tablets (10 mg loratadine, 240 mg pseudoephedrine sulfate), a new once-daily formulation of the widely prescribed nonsedating antihistamine/decongestant combination CLARITIN(R)-D (5 mg loratadine, 120 mg pseudoephedrine sulfate), has received marketing clearance from the U.S. Food and Drug Administration. Available by prescription, CLARITIN-D 24 Hour combines the world's leading nonsedating antihistamine, CLARITIN(R) (10 mg loratadine), with an oral decongestant (240 mg pseudoephedrine sulfate) to make the brand's proven effectiveness more convenient in a once-daily dosing schedule. CLARITIN-D 24 Hour, the first and only once-daily prescription combination product of its kind on the U.S. market, provides relief of nasal symptoms and congestion for a full 24-hour period with one daily dose. Like once-daily CLARITIN and twice-daily CLARITIN-D, CLARITIN-D 24 Hour does not have a black-box warning. "The addition of CLARITIN-D 24 Hour to our already extensive and successful CLARITIN product line reinforces our leadership position in the U.S. allergy/respiratory market," said Richard W. Zahn, president, Schering Laboratories, the U.S. prescription pharmaceutical marketing arm of Schering-Plough. "CLARITIN-D 24 Hour also allows us to broaden the U.S. allergy market and offer consumers another option for safe and effective relief." CLARITIN-D 24 Hour is indicated for the relief of seasonal allergic rhinitis (hay fever) with nasal congestion, a common symptom among many allergy sufferers. It is estimated that 16 million of the 42 million Americans who suffer from seasonal allergic rhinitis also experience nasal congestion. In clinical trials, improvement in nasal and non-nasal symptoms of seasonal allergic rhinitis including nasal congestion in patients receiving CLARITIN-D 24 Hour tablets was significantly greater than in placebo recipients, and was generally greater than with loratadine or pseudoephedrine sulfate alone. "The availability of CLARITIN-D 24 Hour, a unique once-daily formulation, can help improve compliance with therapy for the millions of people who suffer from hay fever with congestion," said William Storms, M.D., associate clinical professor of medicine, University of Colorado Health Sciences Center. "Patients should welcome this new product for its convenience and the effective relief it offers for the treatment of allergy symptoms." Insomnia is a common side effect of many drugs containing pseudoephedrine. However, CLARITIN-D 24 Hour has a low incidence of insomnia, occurring in only 5 percent of patients. Other commonly reported side effects using the recommended dose of CLARITIN-D 24 Hour occurred at a rate similar to placebo and included sedation (6 percent) and nervousness (3 percent). Dry mouth occurred in 8 percent of patients. CLARITIN-D 24 Hour, which will be available nationwide by prescription in early September, can be administered to adults and children 12 years of age and older. The recommended dose is one tablet, once daily. CLARITIN-D will be marketed as CLARITIN(R)-D 12 Hour Extended Release Tablets. Schering-Plough manufactures and markets U.S. prescription pharmaceuticals under its Schering Laboratories, Key Pharmaceuticals and Warrick Pharmaceuticals labels. Major pharmaceuticals include: respiratory products, anti-infectives, anticancer and antiviral products, cardiovasculars and dermatologicals. The company also manufactures and markets animal health and leading over-the-counter (OTC) pharmaceuticals and personal care products. Schering-Plough is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
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