U.S. FDA accepts for review a supplemental New Drug Application to expand labeling of Abilify Maintena® (aripiprazole) for the treatment of Bipolar I disorder
· Application seeks to expand Abilify Maintena label to include maintenance treatment for Bipolar I disorder · If the label expansion is approved, Abilify Maintena would offer prescribers a once-monthly long-acting injectable option in the maintenance treatment of Bipolar I disorder in adults Valby, Denmark and Tokyo, Japan, 30 November 2016 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the U.S. Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena[®]