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| |  FDA Approves Claritin (loratadine) for Over-the-Counter Relief Of Hives KENILWORTH, NJ -- November 20, 2003 -- The U.S. Food and Drug Administration (FDA) today approved the first-ever indication for the over- the-counter (OTC) relief of hives, a common skin condition. Schering-Plough Corporation (NYSE: SGP) announced that new Claritin Hives Relief tablets are the first and only FDA-approved, non-drowsy antihistamine to offer OTC itch relief to adults and children 6 years of age and older who suffer from hives. The once-daily formulation will begin shipping in February 2004 in 10- and 30-count packages. Hives, also known as urticaria, affects approximately 25 percent of the U.S. population at least once in their lives. Hives are raised, itchy welts on the surface of the skin that are triggered by many factors, such as food, medicines, temperature and stress. The welts, which can last from a few hours to several weeks, are pink or red and appear as bumps, blotches or streaks. The triggers cause the release of histamine that in turn causes the symptoms of hives. "Before this approval, many hives sufferers treated their condition with an OTC antihistamine that wasn't FDA-approved for the treatment of hives. If they used an OTC antihistamine for hives relief, they also had to cope with the negative side effects, such as drowsiness or medicine haze, that some medications can cause," said Dr. Leonard Fromer, a Calif.-based, board-certified family practitioner, with a subspecialty in allergies, and a fellow of the American Academy of Family Physicians. "Claritin Hives Relief now offers people with hives a non-drowsy alternative that is clinically proven to safely and effectively relieve itching due to hives, without a prescription." The FDA approved Claritin Hives Relief tablets for the relief of "itching due to hives," which is the most common indicator and most bothersome symptom of the condition. This is an important advancement because no other OTC medication has ever been approved by the FDA for the relief of hives symptoms. The FDA's decision was contingent upon the results of label comprehension studies fielded by Schering-Plough to demonstrate that the label could be properly understood by consumers. Claritin Hives Relief effectively relieves severe itching due to hives. Before Claritin Hives Relief was FDA-approved for OTC use, millions of hives sufferers trusted and used prescription Claritin, which was approved for the treatment of hives to safely relieve their symptoms. Multiple clinical studies in the United States, Canada and other countries around the world have shown that Claritin Hives Relief is safe and well tolerated for the treatment of hives. "With the addition of non-drowsy Claritin Hives Relief Tablets to the first-aid aisle, Schering-Plough is offering millions of hives sufferers a new generation medication," said Dr. John Clayton, senior vice president of scientific and regulatory affairs, Schering-Plough Consumer Health Care. "Before Claritin Hives Relief many people who suffered from hives used OTC treatments that were not approved for hives relief and made them feel drowsy. Now, people who suffer from hives can get effective relief without these side effects. For the first time, FDA approved relief from itching is as close as their local drugstore." For more information on hives, allergy management and Claritin allergy products, please visit http://www.claritin.com.
SOURCE: Schering-Plough Corporation
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