Amarin Corporation PLC (AMRN) Informed by FDA of October 16th Advisory Committee Date in Connection With Supplemental New Drug Application (sNDA) for Vascepa® in the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia
6/19/2013 9:32:05 AM
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BEDMINSTER, N.J. and DUBLIN, Ireland, June 19, 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 it was informed yesterday by the U.S. Food and Drug Administration (FDA) that the FDA will convene an advisory committee on October 16, 2013 in connection with the FDA's review of the Supplemental New Drug Application (sNDA) seeking approval for the use of Vascepa® (icosapent ethyl) capsules as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and <500 mg/dL) with mixed dyslipidemia. The FDA has previously assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013 for completion of its review of the sNDA. The FDA will consider the recommendation of the advisory committee, but the final decision regarding the approval of the sNDA will be made by the FDA.
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