Merck resubmits NDA for ezetimibe, atorvastatin
03 January 2013 | Regulatory | By BioSpectrum Bureau
Merck resubmits new drug application for ezetimibe, atorvastatin
Hopefully the US FDA will complete the review of Merck's New Drug Application (NDA) for ezetimibe and atorvastatin tablets during the first half of 2013
Singapore: US FDA has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine developed by Merck.
Merck expects the FDA's review to be completed during 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.
