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Consumer-Focused Off-Label Promotion Seems Possible After Amarin Settlement

Executive Summary

Legal agreement with FDA allowing communication about off-label Vascepa use is not limited by audience, speaker or setting, attorneys say.

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Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.

Amarin Says REDUCE-IT Results Are Off Limits To Omega-3 Supplement Claims

REDUCE-IT results are limited to Amarin's Vascepa "and cannot be extrapolated to omega-3 products that are materially different based on, for example, composition, dosage, and regulatory status," pharma firm says in complaints against Coromega and Omax. Amarin seeks to stifle the omega-3 supplement firms despite First Amendment argument it made in successful litigation against FDA to make truthful statements about its products even though the information is not approved by the agency.

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