Amarin, FDA Work Toward Settlement In Off-Label Promotion Case

August 31, 2015 at 4:37 PM
A federal circuit court judge agreed Monday (Aug. 31) to give Amarin Pharma Inc. and FDA until the end of October to come up with a settlement in a high-profile case that gave the manufacturer wide latitude to promote its triglyceride-lowering drug Vascepa off-label. In early August, Judge Paul Engelmayer of the Federal District Court for the Southern District of New York granted Amarin a preliminary injunction based on the merits of its contention that FDA's off-label promotion policies violated...


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