Amarin Corp plc. announced the receipt of the anticipated complete response letter from the U.S. Food and Drug Administration (FDA) regarding its Vascepa (icosapent ethyl) capsules ANCHOR trial supplemental New Drug Application (sNDA). Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia. Current Vascepa labeling remains unchanged. The ANCHOR sNDA sought to expand approved Vascepa labeling to include use as an adjunct to diet to reduce TG levels in adult patients on statin therapy with mixed dyslipidemia (one or more lipid disorder) and triglyceride levels from 200 to 499 mg/dL, the ANCHOR population.

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