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Amarin Seeks AMR101 Approval; Hopes To Begin Commercialization Of First Product

This article was originally published in The Pink Sheet Daily

Executive Summary

The New Jersey biotech submitted the NDA for its omega-3 fatty acid drug with FDA.

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Label for Amarin’s EPA-only omega-3 fatty acid therapy notes that in patients with really high triglycerides, triglycerides are lowered significantly with no increase in bad cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza. But contrary to what Amarin wanted, data from a study in healthier patients doesn’t make it into labeling.

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