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.
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