The FDA has accepted and designated a Priority Review for the new drug application (NDA) for prasugrel.
Daiichi Sankyo of Tokyo and the Indianapolis-based Eli Lilly’s prasugrel could potentially present an alternative to physicians who prescribe Plavix, which is used as part of the required gold-standard for patients with ACS being managed with PCI.
The NDA for prasugrel was submitted to the agency on Dec. 26, 2007.
A priority designation by the FDA sets the Prescription Drug User Fee Act (PDUFA) goal date. The PDUFA goal for priority applications is to have an action provided for 90 percent of applications within six months. At that point, the FDA can take three different actions — approved, approvable with further discussion or not approved.