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Amarin Seeks ITC Action Against Products 'Cloaked' As Dietary Supplements

Executive Summary

Seeking to protect its competitive interests, Vascepa marketer asks the US International Trade Commission to investigate importation and sale of synthetically produced omega-3 products by 18 companies; complaint asserts the products at issue are unapproved new drugs that are illegally being marketed as dietary supplements.

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FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients

FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.

FDA Objects To Amarin Trade Complaint Against Omega-3 Ingredients

FDA Chief Counsel Rebecca Wood says Amarin's request for an ITC investigation necessarily turns on questions of drug and supplements policy, where it is the expert and authorized agency. If successful, Amarin's move could encourage others to similarly seek alternative forums for action.

Amarin Makes Flawed Argument In Bid To Drain Omega-3 Market – CRN

CRN recommends the International Trade Commission not investigate Amarin's complaint against dietary supplements containing primarily ethyl ester or re-esterified EPA. The firm markets Vascepa, a synthetically produced ethyl ester drug approved to reduce triglyceride levels in adults with severe hypertriglyceridemia.

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