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Plavix Gets FDA Okay for New Indication

by Medindia Content Team on  April 3, 2002 at 2:19 PM Drug News   - G J E 4
Plavix Gets FDA Okay for New Indication
The antiplatelet medication Plavix (clopidogrel bisulfate) received US Food and Drug Administration approval for use in acute coronary syndrome. People with acute coronary syndrome are at high risk for heart attack, typically because they have unstable angina, or heart disease-related chest pain. About 1.1 to 1.4 million Americans experience acute coronary syndrome each year.
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Plavix was first approved in 1997 for patients with a recent heart attack, stroke or peripheral artery disease. It is marketed worldwide by Bristol-Myers Squibb and Sanofi-Synthelabo. Plavix reduces the "stickiness" of platelets, a type of cell that plays a key role in blood clot formation. It is usually given in addition to aspirin.

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To get FDA approval for acute coronary syndrome, Bristol-Myers submitted data from a trial that was published in The New England Journal of Medicine. In that study, Plavix reduced the risk of heart attack, stroke or cardiovascular death by 20% in acute coronary syndrome patients, when compared with placebo.
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