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Norvasc, First CCB Suitable for Use in Congestive Heart Failure Patients NEW YORK, June 24, 1996 -- New product labeling cleared by the U.S. Food and Drug Administration for the calcium channel blocker Norvasc (amlodipine besylate) shows it to be safe for use in treating hypertension or angina patients who also have congestive heart failure (CHF), Pfizer Inc. (NYSE: PFE) said today. Norvasc, the fastest-growing major cardiovascular medication in the world, is the only calcium channel blocker safe for use in CHF patients, the company said. The U.S. Food and Drug Administration has cleared the revised labeling which is based on data from the Prospective Amlodipine Survival Evaluation (PRAISE) trial, a large morbidity and mortality trial completed last year. "The PRAISE data underscore the unique safety profile and therapeutic benefits of Norvasc," said Joseph Feczko, M.D., vice president and medical director for Pfizer's United States Pharmaceutical Group. "Now physicians have another treatment option for controlling hypertension or angina in patients who have severe CHF and are therefore at significant medical risk." Congestive heart failure refers to the heart's inability to pump sufficient blood to meet the body's needs. The number of patients with CHF, often described as a disease of aging, is expected to double to 6 million by the end of the decade. Discovered and developed by Pfizer, Norvasc is approved for the treatment of angina (chest pain) and hypertension (high blood pressure). Norvasc was tested for its safe use in treating the most severely ill classes of CHF patients in the PRAISE trial. Pfizer Inc. is a research-based, diversified health-care company with global operations. The company reported sales of $10 billion for 1995, and plans to spend approximately $1.7 billion on research and development this year. E-mail this page to a friend or colleague! To print, use this version