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Merck/Schering Zetia Phase IV Minority Study Subject Of Debate At FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA’s request for a Zetia Phase IV study in non-Caucasians was based on the small representation of minorities in pivotal trials for Merck/Schering-Plough’s lipid-lowering agent, as well as concerns about safety and declining efficacy in blacks, NDA review documents show.
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