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FDA Accepts Filing Of The Medicines Company's New Drug Application For Intravenous Antiplatelet Agent Cangrelor


Monday, 1 Jul 2013 08:00am EDT 

The Medicines Company announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the new drug application (NDA) for the Company's investigational intravenous antiplatelet cangrelor. The filing was based on the results of a comprehensive development program, including the data from four randomized, double-blind clinical trials conducted in more than 25,000 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). Cangrelor is intended for use in patients undergoing percutaneous coronary intervention (PCI) and those that require bridging from oral antiplatelet therapy to surgery. 

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25.18
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3:45pm EDT