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Merck fails to secure expanded indications for two cardiovascular products

This article was originally published in Scrip

Executive Summary

The US FDA has declined to approve a new indication for two Merck & Co products, Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe), because the study submitted to the agency did not assess the independent contributions of the individual drugs towards the efficacy result.

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