Amarin, FDA Agree To Allow ‘Truthful, Non-Misleading’ Off-Label Speech About Drug
(March 9, 2016, 2:41 PM EST) -- WASHINGTON, D.C. — Amarin Pharma Inc. and the Food and Drug Administration on March 8 sent a federal judge a proposed settlement in which the FDA agrees that Amarin may engage in “truthful and non-misleading speech” promoting off-label uses of its prescription drug Vascepa to treat patients with persistently high triglycerides (Amarin Pharma, Inc., et al. v. United States Food and Drug Administration, et al., No. 15-3588, S.D. N.Y.).