Amarin, FDA Get More Time in Promotional Lawsuit

The FDA and Amarin have been given another month to negotiate a settlement in their legal feud over promotional claims.

Judge Paul Engelmayer of the U.S. District Court for the Southern District of New York agreed to give the parties until March 18 to settle their differences over Amarin’s efforts to promote its cholesterol drug Vascepa off-label.

The company sued the agency last May, contending that federal promotional regulations prevent it from marketing the drug off-label, even though off-label promotion is not — in and of itself — illegal. The case is notable for an injunction imposed by the judge in August that gives Amarin limited discretion to market Vascepa off-label until the suit is concluded.