The US Food and Drug Administration (FDA) has approved a new indication for Abbott Laboratories' Depakote ER (divalproex sodium extended-release tablets), the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
The extended-release agent offers sufferers of bipolar the convenience of once-daily dosing, sad the company. Abbott’s delayed-release formulation of the drug, Depakote, is already approved for this indication, but Depakote ER helps provide more consistent levels of medication in the body, according to the company.
Charles Bowden, professor of psychiatry and pharmacology at the University of Texas Health Science Center in San Antonio, USA, said: "successful treatment for mania depends upon maintaining steady levels of medication in the blood throughout the day."
Depakote is one of Abbott’s biggest product franchises, bringing in third quarter sales of $263 million dollars, although its growth has stalled of late and it is facing generic competition in 2008 in the USA.