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December 1, 2016

FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena® (aripiprazole) 1xbet 후기

  • Application seeks to expand ABILIFY MAINTENA label to include maintenance treatment 1xbet 후기 bipolar I disorder
  • If 1xbet 후기 label expansion is approved, ABILIFY MAINTENA would offer prescribers a once-monthly long-acting injectable treatment option in 1xbet 후기 maintenance treatment of bipolar I disorder in adults

1xbet 후기., Ltd. (Otsuka) and Lundbeck 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® 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 July 28, 2017, to complete its review.