ABBOTT's DEPAKOTE APPROVAL FOR ACUTE TREATMENT OF MANIC EPISODES RECOMMENDED BY FDA COMMITTEE; COMPANY IS CONDUCTING RELAPSE PREVENTION TRIAL
Executive Summary
Approval of Abbott's Depakote (NDA 20-320) for the acute treatment of manic episodes in bipolar disorder was recommended unanimously by FDA's Psychopharmacologic Drugs Advisory Committee on Feb. 6. The indication for mania, acknowledged to be common clinical practice, would be the third for the oral anti- epileptic divalproex sodium.