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Off-Label Litigation: Amarin Sues FDA In Bid To Promote Vascepa Fish Oil

This article was originally published in The Pink Sheet Daily

Executive Summary

First Amendment lawsuit is most recent challenge of agency’s promotional policies.

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

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.

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

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.

Doctors Often Recommend Omega-3 Supplements For High Cholesterol – Survey

A survey of doctors and pharmacists reports 83% of their patients with abnormally high cholesterol express interest in using omega-3 supplements. But the survey sponsored by Rx omega-3 firm Amarin also raises questions about health care professionals’ knowledge of FDA regulation of supplement products.

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