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news.Daiichi Sankyo and Eli Lilly have reported that the FDA has accepted and designated priority review for the new drug application for prasugrel, for patients with acute coronary syndrome being managed with percutaneous coronary intervention.
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A priority designation by the FDA sets the PDUFA (Prescription Drug User Fee Act) goal date. The PDUFA goal for priority applications is to have an action provided for 90% of applications within six months. FDA can take three different actions, it may be approved, approvable with further discussion, or not approved.
Anthony Ware, vice president for cardiovascular care at Lilly, said: “We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process.”