Otsuka withdraws new labelling request for Abilify in EU
This article was originally published in Scrip
Executive Summary
Otuska Pharmaceutical has withdrawn an EU application seeking to expand the label of Abilify (aripiprazole) as an adjunctive therapy for patients with major depressive disorders. The company has cited a view by the CHMP that long-term data provided in support of the proposed additional indication were insufficient and that a further trial would be needed.