Jun 20, 2008 - Merck & Co., Inc. today provided an update on the regulatory status in the United States of its investigational medicines MK-0524A (ER niacin/ laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
Merck recently met with the U.S. Food and Drug Administration (FDA) to discuss the Not Approvable action letter it received on April 28 in response to its New Drug Application (NDA) for MK-0524A. At the meeting, the FDA stated that additional efficacy and safety data were required and suggested that the Company wait for the results of the HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) cardiovascular outcomes study, which is expected to be completed in January 2013.
The details can be read here.
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