Drug news
Lundbeck + Otsuka file sNDA at FDA for Abilify Maintena (aripiprazole depot) to treat bipolar disorder.
H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announced the FDA has determined that the supplemental New Drug Application (sNDA) for the expanded labeling 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 (PDUFA), the FDA has set a target date of 28 July 2017, to complete its review.
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