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Bayer aspirin MI petition

This article was originally published in The Tan Sheet

Executive Summary

FDA should evaluate collected study data on aspirin for primary prevention of myocardial infarction "expeditiously," Bayer urges in Feb. 22 comments supporting the firm's petition to amend professional labeling to include the indication. The firm submitted data and protocols from five major prevention trials through Colin Baigent, MD, of Oxford's Clinical Trials Study Unit. Baigent previously presented a meta-analysis of the trials at a December 2003 meeting of the Cardiovascular & Renal Drugs Advisory Committee, convened to consider Bayer's petition (1"The Tan Sheet" Dec. 15, 2003, p. 4). The panel voted 11-3 against the new labeling, but the agency requested more information at an April 2004 feedback meeting...

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