Court Vacates FDA’s Denial of Five-Year Exclusivity Period for Amarin’s Vascepa

Amarin Pharmaceuticals Ireland Ltd. notched a win in its ongoing litigation challenging the Food and Drug Administration’s refusal to award a five-year new chemical entity exclusivity period to Amarin’s lipid treatment Vascepa, after a court vacated the FDA’s decision May 28 (Amarin Pharm Ireland, Ltd. v. FDA, 2015 BL 167531, D.D.C., 1:14-cv-00324-RDM, 5/28/15).

In his opinion vacating the FDA’s denial of marketing exclusivity for Vascepa, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia said the FDA’s decision wasn’t a reasonable exercise of its authority and wasn’t entitled to deference.

“The Agency’s ...