Merck receives complete response letter from the U.S. FDA for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin)

15 February 2016 - Merck announced today that the U.S. 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.

For more details, go to: http://www.mercknewsroom.com/news-release/prescription-medicine-news/merck-receives-complete-response-letter-us-fda-zetia-ezetimi

Michael Wonder

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Michael Wonder

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Outcome , US , Submission