Regulatory Actions
FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
Published in Cardiovascular Device Liability Week, July 13th, 2008
Daiichi Sankyo Company, Limited, and Eli Lilly and Company (NYSE:LLY) said that the U.S. Food and Drug Administration (FDA) has extended the review period for the prasugrel new drug application (NDA) based on supplemental information provided during the review period. This three month extension allows the FDA time to complete its review. The prasugrel NDA was granted priority review by the FDA in February 2008. The new FDA action date for prasugrel is September 26, 2008. The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery- opening procedure known as percutaneous coronary intervention (PCI).
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