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Under Proposed Settlement of Amarin, FDA Agrees Drug Manufacturer May Engage in "Off-Label" Promotion

March 14, 2016

In Amarin Pharma, Inc., et al. v. United States Food & Drug Admin., et al., drug manufacturer Amarin sought a preliminary injunction allowing it to make truthful and non-misleading statements promoting an "off-label" use of drug Vascepa. Vascepa was approved by the FDA to treat "very high" triglyceride levels, and Amarin sought to promote Vascepa for the treatment of "high" triglyceride levels. The FDA threatened a misbranding prosecution, and Amarin sought preliminary relief to ensure its ability to engage in truthful and non-misleading speech free from the threat of a misbranding action.

The U.S. District Court for the Southern District of New York granted a preliminary injunction on August 7, 2015, declaring:

"(1) Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persi