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FDA “Approves” Amarin Vascepa Off-Label Campaign; Industry Groups Urge Court Not To Take The Bait

This article was originally published in RPM Report

Executive Summary

FDA has given Amarin the go-ahead to disseminate results from the ANCHOR trial despite rejecting an explicit claim based on the study. That sounds like good news – except that it comes in the context of ongoing litigation, and amounts to an attempt to render the case irrelevant without surrendering control over off-label dissemination policies.

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