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) --The U.S. Food and Drug Administration on Thursday approved a prescription fish-oil pill from


(AMRN) - Get Amarin Corp. Plc Report

that will be used to treat patients with very high levels of triglycerides, a type of fat found in blood.

Amarin's newly approved drug Vascepa is made from ultra-purified ethyl EPA, an omega-3 fatty acid commonly found in fish. An FDA spokesperson confirmed the approval.

An FDA decision on whether Vascepa will be granted five years of market exclusivity as a New Chemical Entity (NCE) has not been announced and won't likely be public until August, Amarin said in a statement.

Shares of Amarin were halted ahead of the Vascepa approval announcement at $15.31.

When taken daily at its highest dose, Vascepa lowered triglyceride levels by 33% compared to a placebo in a phase III clinical trial that enrolled patients with very high baseline levels (greater than 500 mg/dl) of the blood fat. Vascepa also did not cause a significant increase in LDL, or "bad" cholesterol.

Vascepa will compete against a similar prescription-grade fish oil pill marketed by


(GSK) - Get GlaxoSmithKline Plc Report

known as Lovaza, which generates about $1 billion in annual sales.

Amarin is planning on a Vascepa commercial launch in the first quarter of 2013. Who launches the drug is still being determined. Amarin said it is still pursuing three options: A sale of the company, a partnership or marketing the drug on its own.

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