FDA Approves New Indication For Plavix (clopidogrel Bisulfate) Offering New Option For Patients With Most Severe Type Of Heart Attack:
"Sanofi-aventis and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for the antiplatelet agent PLAVIX(clopidogrel bisulfate) to reduce the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke or death in patients with acute ST-segment elevation myocardial infarction (STEMI). STEMI is a severe acute heart attack in which a coronary artery is generally blocked completely. These blockages are caused by clot formation in the arteries, a life-threatening complication of an underlying disease known as atherothrombosis. However, this benefit is not known to pertain to patients who receive primary angioplasty.

'Clopidogrel taken with aspirin has previously been shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks,' said Dr. Marc Sabatine, TIMI Study Group, Brigham and Women's Hospital. 'Now, based on the positive results of two clinical trials, COMMIT and CLARITY-TIMI 28, clopidogrel has been approved by the FDA for use with aspirin in patients with the most severe types of heart attacks, thereby extending the benefit of clopidogrel to patients across the spectrum of acute coronary syndromes.' ...."