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Merck's NDA For A Pill That Combines Zetia And Lipitor Is Bounced By FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Citing a need for more data, the agency refuses to file an NDA for a pill combining ezetimibe (Zetia) and atorvastatin (Pfizer's Lipitor).

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

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.

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

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