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Omacor Data Inadequate To Support Use With Statins, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Added benefit was seen with simvastatin, but reviewers noted that statin doses in studies were too low. Labeling makes no mention of concomitant use with statins or other lipid-altering therapies. Reliant is pursuing additional indications for the omega-3 fatty acids product, including possible use with statins or its fenofibrate Antara.

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