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| |  Nicoderm Cq Approved for Over-the-Counter Use PITTSBURGH, Aug. 2, 1996 -- SmithKline Beecham and Hoechst Marion Roussel jointly announced today that the U.S. Food and Drug Administration (FDA) has approved NicoDerm(R) CQ(TM), the most widely prescribed nicotine patch in the U.S., for over-the-counter (OTC) sale as a stop smoking aid. Nicoderm(R) has been used safely and effectively by an estimated four million smokers since its introduction as a prescription product in 1991. NicoDerm CQ will be available in stores before Labor Day. NicoDerm CQ is the first and only OTC nicotine patch to be available in all prescription strengths: 21 mg, 14 mg and 7 mg per day. NicoDerm CQ provides a simple step down program that allows smokers to gradually reduce their nicotine intake, rather than stop abruptly. Most smokers should start with Step 1 (21 mg) for six weeks; step down to Step 2 (14mg) for two weeks; and then use Step 3 (7 mg) for two weeks. NicoDerm CQ is also the only OTC nicotine patch approved for light smokers. Those who smoke 10 or fewer cigarettes a day should start with the Step 2 (14 mg) dose for six weeks and then step down to the Step 3 (7 mg) dose for two weeks. "Each year, as many as 16 million Americans make a serious attempt to give up smoking," said George Quesnelle, Vice President and Director, Medical Marketing and Sales, SmithKline Beecham Consumer Healthcare. "As the leader in the OTC smoking cessation category, our company is proud to provide these people with the first OTC patch that allows smokers to step down their addiction to nicotine in a safe, effective and simple manner." SmithKline Beecham introduced Nicorette(R), the first NRT product to be available without a prescription, earlier this year. NicoDerm CQ is the only patch that can be worn for either 16 or 24 hours. Smokers who crave cigarettes when they wake up can wear the patch for 24 hours. Purchase of NicoDerm CQ also offers the option of free enrollment in Committed Quitters(TM), a personalized behavioral support program. A unique profile and quitting plan is developed for each user who will receive a series of customized self-help materials throughout the 10-week therapy. Certain patient populations should seek the advice of a health professional prior to starting therapy with nicotine patches. These include people under age 18; people with heart disease, an irregular heartbeat or who have had a recent heart attack; people with high blood pressure not controlled with medication; people taking prescription medicine for depression or asthma; or people with The most frequently reported adverse events associated with nicotine patches are usually mild and include short-lived itching or burning at the site of application and dizziness. SmithKline Beecham will be responsible for the marketing of NicoDerm CQ in a joint venture with Hoechst Marion Roussel. In 1992, SmithKline Beecham and Hoechst Marion Roussel created a partnership to market OTC products. ALZA Corporation, which developed the product, will manufacture NicoDerm CQ. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines, health-related consumer products and healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management. Hoechst Marion Roussel, a world leader in pharmaceutical-based healthcare, is dedicated to extending and enhancing human life through the discovery, development, manufacturing and sale of pharmaceutical products. Hoechst Marion Roussel is a member of the Hoechst Group. ALZA Corporation, headquartered in Palo Alto, California, is a leader in the development and commercialization of innovative pharmaceutical products using advanced drug delivery technologies to add medical and economic value to drug therapies.
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