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.