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Amarin Says FDA Accepts Supplemental New Drug Application for Vascepa

Amarin Corp. (AMRN) said the U.S. Food and Drug Administration accepted its supplemental new drug application for the cholesterol-reducing fish-oil pill Vascepa and has set a Dec. 20 target date to complete its regulatory review.The biotechnology company is seeking approval of Vascepa as an adjunct to diet for the treatment of adults with high triglycerides with mixed dyslipidemia."We are very pleased that the FDA has accepted our sNDA submission for the Anchor indication, which supports the potential expansion of the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 [micrograms per decilitre] and mixed dyslipidemia," said Chairman and Chief Executive Joseph S. Zakrzewski.The FDA in July approved Vascepa for patients with elevated blood-fat levels but left undecided whether the drug should be deemed a "new chemical entity" because it has some similarity to a pill already on the market from GlaxoSmithKline PLC (GSK, G...

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