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Non-Fatal MI Prevention Indication For Aspirin May Cause Bayer Less Pain

This article was originally published in The Tan Sheet

Executive Summary

Bayer may have a better shot of gaining FDA approval of expanded professional labeling for aspirin by pursuing an indication for prevention of non-fatal myocardial infarction. The firm got a negative advisory committee vote for prevention of all MIs at a Dec. 8 meeting

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Aspirin Labeling Should Reflect Risk-Based CVD Prevention, Bayer Says

Aspirin therapy labeling should be revised to include an indication for primary prevention of myocardial infarction, reflecting a risk-based approach to cardiovascular disease prevention, Bayer maintains in a recent submission to FDA

Aspirin Labeling Should Reflect Risk-Based CVD Prevention, Bayer Says

Aspirin therapy labeling should be revised to include an indication for primary prevention of myocardial infarction, reflecting a risk-based approach to cardiovascular disease prevention, Bayer maintains in a recent submission to FDA

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