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Court Approves Proposed Settlement Terms in Amarin First Amendment Litigation - Allows Off-label Promotion of Vescepa

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Additional Relevant Details The FDA/US Government have agreed with Amarin to be bound by the court's earlier decision on August 7, 2015 that stated Amarin may "engage in truthful and non-misleading speech promoting the off-label use of Vascepa".  Vescepa is currently in a REDUCE-IT trial testing whether it will significantly reduce cardiovascular risk with statin treatment compared to statins alone in high-risk patients with elevated triglyceride levels.
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Mar 09, 2016
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Related Keywords Court Settlement, First Amendment Litigation, Vescepa, Cardiovascular Disease, Omega-3