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Amarin Announces FDA DMEP Does Not Plan to Re-instate ANCHOR SPA Agreement

Amarin (Nasdaq: AMRN) announced today that the Division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement."

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Posted-In: News Guidance FDA Management Global

 

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