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Vytorin/Zetia Affirmation Continues To Elude Merck With Denied CKD Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA shot down Merck’s bid to add an indication for cardiovascular risk reduction in renally impaired patients to Vytorin (ezetimibe/simvastatin) labeling, arguing the contribution of the two components to positive results wasn’t measured in the pivotal SHARP trial. Trial data can be added to the Vytorin label but not to labeling for Zetia (ezetimibe).

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