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Merck/Schering Zetia Effects On Triglycerides, HDL-C Questioned In Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA and Merck/Schering-Plough reached a middle ground on Zetia’s indication, allowing the “small” and “variable” effects on triglycerides and HDL-cholesterol to be described in the clinical studies section of labeling, but not permitting inclusion in the indications section, FDA review documents show.

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