Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease.
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The applications were based on the results of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial). Merck is reviewing the letter and will determine next steps.
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ZETIA and VYTORIN are indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. VYTORIN contains 2 active ingredients: ezetimibe and simvastatin. No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
