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.