The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications. The Advisory Committee voted unanimously that prasugrel should be approved for the treatment of patients with acute coronary syndromes undergoing PCI. Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee TOKYO and INDIANAPOLIS, / - / -- The U.S. "Today's scientific exchange set the stage for a potential FDA approval of prasugrel, and the future availability of this significant scientific advancement for the treatment of ACS-PCI patients." "We will continue to work closely with the FDA as the agency moves toward an action on the new drug application for prasugrel," said J.

Anthony Ware, M.D., Magdalene vice president and cardiovascular/acute care platform leader for prasugrel. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 that prasugrel, an investigational antiplatelet agent, should be approved for the treatment of patients with acute coronary syndromes (ACS) managed with an artery-opening procedure known as percutaneous coronary intervention (PCI), Daiichi Sankyo Company, Limited, (TSE. "It is important for patients to have multiple treatment options, and currently, ACS.

"We are very proud of the prasugrel data," said Grange Immanuel M.D., M.P.H., global head of research and development, Daiichi Sankyo Company, Limited.

4568), and Eli Alyson and Company (NYSE.