Posted by Michael Wonder on 01 Dec 2016
U.S. FDA accepts for review a supplemental new drug application to expand labelling of Abilify Maintena (aripiprazole) for the treatment of bipolar I disorder
30 November 2016 - Application seeks to expand Abilify Maintena label to include maintenance treatment for bipolar I disorder.
Lundbeck) and Otsuka today announced the U.S. FDA has determined that the supplemental new drug application for the expanded labelling of Abilify Maintena for the maintenance treatment of bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed.
Under the Prescription Drug User Fee Act, the FDA has set a target date of 28 July 2017, to complete its review.
