Amarin Pharma Inc., maker of high-concentration EPA-only omega-3 drug Vascepa, has reached a settlement with omega-3 dietary supplement companies The Coromega Company, Inc., and Omax Health, Inc over complaints the drug company filed in October of 2018.
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Amarin Pharma Inc. (Dublin, Ireland), maker of high-concentration EPA-only omega-3 drug Vascepa, has reached a settlement with omega-3 dietary supplement companies The Coromega Company, Inc., and Omax Health, Inc over complaints the drug company filed in October of 2018. The lawsuits alleged that the supplement companies were using recently-published topline results of Amarin’s own REDUCE-IT clinical trial to bolster the marketing of their own omega-3 supplement products.
As part of the settlement, both Coromega and Omax Health have agreed to post corrective statements on their respective websites that make clear the REDUCE-IT study is only applicable to Vascepa, and was not designed to test the efficacy of any dietary supplement. They must also make clear in the corrective statements that federal law prohibits dietary supplements to make claims that they can treat, mitigate, or prevent diseases such as cardiovascular disease, and from suggesting that a supplement can substitute disease therapies. Additionally, the settlement bars the companies from further suggesting the results of the REDUCE-IT study imply similar results from the use of dietary supplements, making any statement regarding the comparability, substitutability, or superiority of their dietary supplements over Vascepa, or claiming that their omega-3 supplements can lower or reduce high triglycerides.
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