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Amarin Receives FDA Notification That Action on ANCHOR sNDA Review Will be Delayed

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Amarin (Nasdaq: AMRN) announced today that the U.S. Food and Drug Administration (FDA) notified the company last night that the FDA does not expect to take action on Amarin's supplemental new drug application (sNDA) for the proposed ANCHOR indication labeling expansion for Vascepa® (icosapent ethyl) capsules on the December 20, 2013 Prescription Drug User Fee Act (PDUFA) goal date because Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement remains under consideration with the FDA. No new PDUFA date was established.

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Posted-In: News Contracts FDA Management Global

 

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