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Zetia/Lipitor Combo’s Ongoing Clinical Equivalence Trials May Address FDA’s Data Request, Merck Says

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA did not accept the company’s bioequivalence arguments supporting a fixed-dose combination of ezetimibe and atorvastatin. Merck believes new data that are expected to be available later this year may address the agency’s “complete response” letter.

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