FDA acknowledges resubmission of Merck’s NDA for ezetimibe and atorvastatin tablets
Published on January 3, 2013 at 12:45 AM
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.
Merck is continuing to move forward with planned filings for the ezetimibe and atorvastatin combination tablet in additional countries around the world.