Amarin Given 3-Year Exclusivity for Vascepa

Amarin (NASDAQ: AMRN  ) 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."


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  • Report this Comment On February 22, 2014, at 7:30 AM, dontworrycmurray wrote:

    Well Well, Would you expect anything else from this corrupt FDA. They have attempted at every turn to block Amarin from being successful with its great drug. Go down the list of denials and if you cant smell corruption you are looking through dark color glasses.

  • Report this Comment On February 22, 2014, at 12:59 PM, meme123456 wrote:

    Did you forget to mention, "Such exclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments"?

  • Report this Comment On February 22, 2014, at 5:19 PM, wayouy wrote:

    Ask why the FDA only gave 3 year exclusivity, maybe because they waited 2 years before NCE? This is so obvious, FDA in bed with BP to crush AMRN. What about all the off label GSK has with Lovazia for TG BELOW 500! I do not know the number, but suspect it to be substantial. The fix is in. Imagine what would happen if AMRN was granted label extension for TG above 200 and GSK lost that off label business that AMRN has approval on. Follow the $$$. That is why the FDA will not approve off label until after the studies in 2017, even though Jelis study already proves the theory. COLLUSION, imo. This is a safe and effective drug.

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