FDA Issues Early Communication About An Ongoing Review Of Vytorin

The U.S. Food and Drug Administration issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study - the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) - on this cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.

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Filed under: Cholesterol on January 29th, 2008