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Aspirin professional labeling indication for suspected acute MI proposed by FDA.

This article was originally published in The Tan Sheet

Executive Summary

ASPIRIN INDICATION FOR SUSPECTED ACUTE MI PROPOSED by FDA in a notice published in the June 13 Federal Register. The agency's proposal to amend the tentative final monograph for OTC internal analgesic, antipyretic and antirheumatic drug products calls for changes to the professional labeling of products containing aspirin, buffered aspirin and aspirin in combination with antacid. Amendments would include an indication for reduction of "the risk of vascular mortality in people with suspected acute myocardial infarction (MI)." Written comments on the proposal are due Sept. 11.
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