FDA refuses to file Merck application for combo of ezetimibe and atorvastatin

The FDA has refused to accept Merck’s application for a  combination  drug consisting of ezetimibe and atorvastatin. Here is the statement from Merck, buried on page 46 of Merck’s quarterly report:

The Company submitted for filing an NDA with the FDA for MK-0653C, ezetimibe combined with atorvastatin, which is an investigational medication for the treatment of dyslipidemia being developed by the MSP Partnership, and the FDA recently refused to file the application. The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA’s response in order to determine a new timetable for filing.


  1. […] which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last […]

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