The FDA will not take action on Amarin‘s sNDA for Vascepa (icosapent ethyl) capsules by the Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2013. The delay is due to 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 sep...