FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin

The FDA rejected a new indication for Merck’s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of SHARP (Study of Heart and Renal Protection), which found that Vytorin reduced the incidence of…

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