Abbott neurology news
Abbott will pay $1.5 billion to federal and state authorities to resolve criminal and civil liability regarding past marketing activities for neurology drug Depakote divalproex. Under the settlement, Abbott pleaded guilty to a misdemeanor violation for misbranding Depakote, which is approved in the U.S. to treat epileptic seizures and bipolar mania and to prevent migraines. The U.S. Department of Justice said the company unlawfully promoted off-label use of Depakote in nursing homes from 1998 through 2006 to control agitation and aggression in elderly dementia patients and to treat schizophrenia. Additionally, DoJ said the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia despite clinical trials failing to show that adding Depakote was more effective than an atypical antipsychotic drug alone. Abbott had included a $1.5 billion charge for litigation reserves related to Depakote marketing activities in its 3Q11 earnings statement in October. In its fiscal 2007 10-K, the company said U.S. sales of Depakote were $1.5 billion. The patent covering U.S. composition of matter for the product expired in July 2008. ...