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AMARIN CORPORATION PLC (ADR)

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Amarin Corporation plc (ADR) : Amarin Receives FDA Notification That Action on ANCHOR sNDA Review Will be Delayed

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12/20/2013 | 07:34am EDT

BEDMINSTER, N.J. and DUBLIN, Ireland, Dec. 20, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, 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.

The FDA also communicated to Amarin that it now views Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin's request to re-instate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA.

Vascepa is currently FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (

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