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Amarin Given 3-Year Exclusivity for Vascepa

By Eric Volkman – Feb 21, 2014 at 10:05PM

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Amarin is granted exclusivity from the FDA, but was hoping for a longer term.

Amarin (AMRN -4.27%) has received an important approval from the Food and Drug Administration, but the company is not necessarily happy about it. The FDA  awarded the firm three years of marketing exclusivity for Vascepa capsules. That approval expires in July 2015, as it is backdated to the original approval granted Vascepa for the treatment of severe hypertriglyceridemia. This disorder is the overabundance of triglycerides, a fatty molecule, which puts the afflicted party at risk of pancreatitis.

In the press release announcing the news, Amarin made little attempt to hide its dissatisfaction with the term of the approval, hinting at a potential effort to lengthen it. The firm quoted its CEO John Thero as saying that, "Amarin is reviewing the FDA's reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision."

Eric Volkman has no position in Amarin. Nor does The Motley Fool. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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