Vytorin Label Will Include Kidney Data

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The FDA has approved new labeling for the cardiovascular agent Vytorin (ezetimibe/simvastatin) that will include data from the Study of Heart and Renal Protection (SHARP), in which Vytorin 10/20 mg reduced the risk for major vascular events in persons with moderate to severe chronic kidney disease.

However, the FDA did not approve a new related indication for Vytorin because SHARP did not assess the independent contributions of ezetimibe and simvastatin to the observed effect.

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