FDA Acknowledges Resubmission of Ezetimibe/Atorvastatin NDA
Merck announced that the FDA has acknowledged the resubmission of a New Drug Application (NDA) for the investigational ezetimibe and atorvastatin tablet combination. Ezetimibe is a cholesterol absorption inhibitor; atorvastatin is an HMG-CoA reductase inhibitor.
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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