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Merck
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.
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