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Aspirin professional labeling

This article was originally published in The Tan Sheet

Executive Summary

"A final rule must be published now without further delay" approving aspirin for "long-term use in women and men at lower doses and for additional indications including: acute MI, stable angina, revascularizations and minor stroke" the American Heart Association, the American College of Cardiology and the National Stroke Association declare in June 12 comments to FDA. "It would be better to publish this rule" than to wait for "stroke data that has been slow in coming," the groups say, adding "a future update might also include primary prevention, atrial fibrillation and the results of other newer studies." FDA has said the final rule is nearing completion and may include recommendations made by FDA advisory committees in addition to the indication, for suspected acute MI, proposed by FDA in June 1996 ("The Tan Sheet" Sept. 1, 1997, p. 5). Other cardiovascular indications were included in aspirin professional labeling under the 1988 TFM for internal analgesics...
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