Elan Pleads Guilty in Federal Court for Off-Label Marketing of Zonegran

Irish drugmaker Elan has pleaded guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act for promoting its epilepsy drug Zonegran for off-label uses. The plea, which was entered by the company Monday in the U.S. District Court for the District of Massachusetts, marks the final step in the drugmaker’s $203.5 million settlement of the case that was reached with the Justice Department late last year. As part of its settlement, Elan agreed to pay $102 million to resolve civil False Claims allegations, as well as a $97 million criminal fine and will forfeit $3.6 million in assets.
Drug Industry Daily