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FDA Approves First Bi-Monthly Injectable for Schizophrenia, Bipolar 1

Results validate the established safety and efficacy profile of the once-monthly aripiprazole injection.

The U.S. FDA approved Otsuka and Lundbeck’s extended-release injectable formulation of aripiprazole, now to be marketed as Abilify Asimtufii, for the treatment of schizophrenia or as maintenance therapy for bipolar I disorder. Abilify Asimtufii is the first long-acting injectable for these indications that only needs to be administered once every two months, according to the companies. The new formulation is approved for use in adult patients. Otsuka and Lundbeck supported Ability Asimtufi...

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