In Brief: Abbott Depakote
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"...
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth