FDA to Review Abilify Maintena for Bipolar I Disorder
Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena (aripiprazole extended-release) for the maintenance treatment of bipolar I disorder in adults.
The sNDA is seeking to include maintenance treatment for bipolar I disorder. The FDA has determined that the application is sufficiently complete for a substantive review.
Abilify Maintena, an atypical antipsychotic, is indicated to treat schizophrenia and Tourette's disorder. Each vial or pre-filled syringe contains 300mg or 400mg aripiprazole extended-release injectable suspension for intramuscular (IM) injection after reconstitution. The efficacy of aripiprazole may be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of July 28, 2017.
For more information call (800) 441-6763 or visit AbilifyMaintena.com.