US FDA seeks additional data from Merck's NDA for ezetimibe & atorvastatin tablets
The US Food and Drug Administration (FDA) has issued a Complete Response Letter to Merck, known as MSD outside the United States and Canada, regarding its new drug application for ezetimibe and atorvastatin tablets, an investigational combination medicine.
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.