FDA refuses to approve lipid-lowering combination of atorvastatin and ezetimibe (Merck)

The FDA has issued a Complete Response Letter regarding Merck's new drug application ezetimibe and atorvastatin tablets, an investigational combination medicine for Dyslipidaemia. In the letter, the agency advised Merck that it has completed its review of the submission and stated that additional data are needed. Merck plans to discuss next steps with the agency in the near future, including new data that are expected to be available later this year, which may address the FDA's comments. Studies testing different dose combinations of ezetimibe/atorvastatin on LDL-cholesterol levels against ezetimibe and atorvastatin alone are currently in Phase III trials. Atorvastatin came off patent in the US in 2011.