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The Medicines Co receives complete response letter from FDA requesting additional information for new drug application for its antiplatelet agent cangrelor


Wednesday, 30 Apr 2014 10:00pm EDT 

The Medicines Co:Announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the company's new drug application for its investigational intravenous antiplatelet agent cangrelor.For the PCI indication, the Agency stated that the application cannot be approved at the present time.The agency suggested that the company perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management, and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials.The Agency provided additional comments for the company to address, stating that the comments are not currently approvability issues, but could affect labeling. 

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27.34
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26 Dec 2014