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FDA to weigh new use for Amarin drug

Published 06/20/2013 12:00 AM
Updated 06/19/2013 11:42 PM

Amarin Corp. plc, the Irish biotech with R&D headquarters in Groton, announced Wednesday that the U.S. Food and Drug Administration will convene an advisory committee Oct. 16 to consider a supplemental new drug application for heart pill Vascepa.

The advisory committee is expected to vote on whether to recommend the approval of Vascepa for people with elevated levels of fat in their blood who do not currently have a prescription option for lowering heart-clogging triglycerides. Vascepa is currently approved only for people with dangerous triglyceride levels.

FDA is expected to complete its review of Vascepa for the new indication by Dec. 20.

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