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Amarin Prescription Fish-Oil Pill Approved

Updated with new information.

BEDMINSTER, NJ ( TheStreet) --The U.S. Food and Drug Administration on Thursday approved a prescription fish-oil pill from Amarin (AMRN) 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 GlaxoSmithKline (GSK - Get 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.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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