The Department of Justice on Thursday announced that UCB pled guilty and agreed to pay $34.4 million to resolve criminal and civil liability charges related to its misbranding Keppra (levetiracetam) for migraines.
Specifically, the company pled guilty to one count of promoting the epilepsy drug for migraine in the US in 2004 without the necessary FDA approval.
UCB will pay approximately $8.6 million in criminal fines and forfeiture for violating the federal Food, Drug and Cosmetic Act and a further $25.8 million to settle a separate civil case involving claims filed by US federal healthcare programmes.
As part of the settlement, the drugmaker also agreed to enter into a five-year corporate integrity agreement with the Office of Inspector General.
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"