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  5. FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena® (aripiprazole) For T1xbet 후기 Treatment Of Bipolar I Disorder

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December 1, 2016

FDA Accepts For Review A Supplemental New Drug Application To Expand Labeling Of Abilify Maintena® (aripiprazole) For T1xbet 후기 Treatment Of Bipolar I Disorder

  • Application seeks to expand AB1xbet 후기IFY MAINTENA label to include maintenance treatment for bipolar I disorder
  • If t1xbet 후기 label expansion is approved, ABILIFY MAINTENA would offer prescribers a once-monthly long-acting injectable treatment option in t1xbet 후기 maintenance treatment of bipolar I disorder in adults

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announced t1xbet 후기 U.S. Food and Drug Administration (FDA) has determined that t1xbet 후기 supplemental New Drug Application (sNDA) for t1xbet 후기 expanded labeling of ABILIFY MAINTENA® for t1xbet 후기 maintenance treatment of bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed. Under t1xbet 후기 Prescription Drug User Fee Act (PDUFA), t1xbet 후기 FDA has set a target date of July 28, 2017, to complete its review.

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