
Amarin and FDA Reach Settlement of Off-Label Promotion Case
Amarin Pharma, Inc. and the U.S. Food and Drug Administration filed a proposed settlement with Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York that would end their litigation over Amarin’s off-label promotion of Vascepa. The settlement provides that Amarin will not be prosecuted for truthful and non-misleading promotion of Vascepa outside of its approved label. [3/10/16]