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Possible FDA/Amarin Off-Label Deal; Rule Tweaks Ahead?

This article was originally published in Scrip

Executive Summary

The FDA appears to be headed towards a settlement with Amarin over the company's challenge that it has the right to share "truthful and non-misleading" information about the unapproved uses of its fish-oil pill Vascepa (icosapent ethyl) – a case in which the biotech was handed a big win on Aug. 7.



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