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Merck's Vytorin/Zetia Headed For CV Outcomes Claim, But Will Dialysis Patients Be Off-Limits?

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously endorses cardiovascular risk reduction claim for pre-dialysis chronic kidney disease patients, but votes 10-6 against extending the indication to the dialysis setting due to efficacy concerns.

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The SHARP “Approval”: Merck Gets Vytorin Labeling Change, But Not The CV Outcomes Claim It Sought

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