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.