Amarin Says No FDA Decision Yet on NCE Exclusivity for Vascepa

In an Oct. 10 filing with securities regulators, Amarin Corp. announced that the Food and Drug Administration has not yet made a determination on its pending request for five-year, new chemical entity (NCE) exclusivity for Vascepa (icosapent ethyl) capsules.

FDA approved Vascepa in July as an adjunct to diet, to reduce triglyceride levels in adults with very high triglycerides (10 PLIR 1011, 8/3/12). When the drug was approved, Dublin-based Amarin said it was awaiting a decision from FDA as to whether the product will be granted five-year NCE or three-year new product marketing exclusivity under the Hatch-Waxman amendments ...