www.fdanews.com/articles/175425-fda-issues-complete-response-letter-to-merck-for-zetia-vytorin-sndas
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FDA Issues Complete Response Letter to Merck for Zetia, Vytorin sNDAs
February 22, 2016
The FDA has issued a complete response letter to Merck & Co. for its sNDAs for cholesterol drugs Zetia and Vytorin to reduce the risk of cardiovascular events in patients with coronary heart disease.
Merck said it is reviewing the letter and will determine next steps. A spokesman declined to comment further.