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FDA to consider expanding Abilify Maintena label to bipolar I disorder
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Otsuka and Lundbeck recently announced the FDA accepted a supplemental New Drug Application to expand labeling of Abilify Maintena for maintenance treatment of bipolar I disorder in adults.
According to a company press release, the FDA deemed the supplemental New Drug Application sufficiently complete to review.
The FDA set July 28, 2017 as a target date for completion of the review.
Approved in 2013 for treatment of schizophrenia in adults, Abilify Maintena is an extended-release injectable suspension of aripiprazole for intramuscular use.
After initial injection, individuals receive an overlapping 14-day dosing of oral antipsychotic treatment and subsequent injections of Abilify Maintena to provide medication coverage for 30 days at a time.
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