FDA Denied: Federal Judge Grants Amarin Permission to Promote Fish Oil Drug

Published: Aug 10, 2015

A Federal judge in New York today granted Amarin Pharma’s request for an injunction against the enforcement by the U.S. Food & Drug Administration of rules that would otherwise prohibit the communication to physicians of truthful information about unapproved uses of its product Vascepa® (isocapent ethyl).

Today’s ruling follows the 2012 opinion by the U.S. 2nd Circuit Court of Appeals in United States v. Caronia that tossed out a misbranding conviction on the basis of the promotion of Jazz Pharmaceutical’s drug Xyrem® (sodium oxybate) by a sales representative for conveying truthful and non-misleading information to doctors.

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