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

Executive Summary

FDA opted against a new indication for the ezetimibe/simvastatin combination because the SHARP trial in chronic kidney disease patients did not assess the independent contributions of each drug on the observed effect. There was no indication at a November advisory committee review that issues related to the “combination rule” would pose a barrier to a new claim.

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