FDA Issues Complete Response Letter for Merck’s sNDA for Cholesterol Drugs

The US Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck & Co.’s supplemental new drug applications for the anticholesterol drug, Zetia (ezetimibe) and Vytorin (zetimibe and simvastatin) 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. Merck is reviewing the letter and will determine next steps.

Zetia and Vytorin are indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia.

Source: Merck & Co.

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