In Brief: Abbott Depakote

Executive Summary

Abbott Depakote: Company no longer pursuing indication for prevention of secondarily generalized seizures. Abbott sought the indication in conjunction with its recently approved NDA for Depakote in the treatment of complex partial seizures with or without secondary generalization ("The Pink Sheet" July 1, T&G-2). In its June 20 approval letter for the new Depakote indication, FDA's Division of Neuropharmacological Drug Products concludes that "the analyses you have submitted do not establish the effectiveness of Depakote in preventing secondarily generalized seizures." FDA explains that "while such an effect was demonstrated in study M89-318, no statistically significant treatment differences were demonstrated in study M88-194, either in the original analysis performed or the conditional analysis we requested in our Nov. 29, 1995 approvable letter"...