Otsuka Pharmaceuticals and Lundbeck's supplemental New Drug Application for the
expanded labeling of ABILIFY MAINENA has been completed and will receive a substantive review by the U.S. Food and
Drug Administration.
In Accordance with the Prescription Drug User Fee
Act, the FDA has set a target date of July 28, 2017 to complete
its review of the Otsuka sNDA.
Otsuka ABILIFY MAINENA sNDA under review by FDA
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