UCB admits Keppra misbranding offence

UCB has agreed to pay $34.4m to settle a dispute with the US Department of Justice regarding off-label marketing of its epilepsy drug Keppra.

The Belgian company's US subsidiary pleaded guilty to a single misdemeanour violation and entered into a separate civil settlement agreement to resolve allegations relating to misbranding of Keppra (levetiracetam) as a migraine treatment.

Greg Duncan, UCB's president for North American operations, said: "We have worked diligently over the years to enhance our compliance programme and we continue to evolve our compliance efforts to meet the changing demands of the regulatory environment in which we operate. We are pleased to have resolved this matter."

The events occurred more than six years ago, and UCB said it cooperated fully with the US authorities since learning of the investigation in 2008. It also signed a five-year corporate integrity agreement with the US Department of Health and Human Services.