Merck (MRK) Resubmits NDA for Ezetimibe, Atorvastatin Tabs
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Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. The updated NDA was deemed complete for review after Merck submitted additional data in response to the FDA’s Complete Response Letter issued last year. Merck expects the FDA’s review to be completed in the first half of 2013.
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