US OK For Pfizer's Norvasc In CHF

30 June 1996

Norvasc (amlodipine besylate), the fastest-growing major cardiovascular drug in the world, "is the only calcium channel blocker safe for use in treating hypertension or angina patients who also have congestive heart failure," according to the drug's maker, Pfizer.

The US Food and Drug Administration last week cleared new product labeling, based on data from a large morbidity and mortality trial completed last year, the Prospective Amlodipine Survival Evaluation (PRAISE) trial, which allows this indication for Norvasc.

In a press statement, Pfizer notes that the PRAISE data underscores the safety of Norvasc, and says 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.

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