BioCentury
ARTICLE | Company News

Amarin endocrine/metabolic news

March 14, 2016 7:00 AM UTC

FDA agreed to be bound by the Aug. 7, 2015, preliminary injunction by the U.S. District Court for the Southern District of New York allowing Amarin to make truthful, non-misleading statements about off-label use of Vascepa icosapent ethyl to treat persistently high triglycerides. Under the settlement, FDA agreed that truthful, non-misleading promotion of the more than 96% pure ethyl ester of eicosapentaenoic acid (ethyl-EPA) “may not form the basis of a prosecution for misbranding,” and that statements the court approved in August meet the truthful, non-misleading standard (see BioCentury, Aug. 17, 2015). ...