Otsuka, Lundbeck Win U.S. Approval for Monthly Abilify Shot
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Otsuka Holdings Co. and H. Lundbeck A/S won approval from U.S. regulators to market a new formulation of the mood-stabilizing drug Abilify as a once-monthly injection to treat schizophrenia.
The Food and Drug Administration cleared Abilify Maintena, a freeze-dried version of Abilify reconstituted with water to allow for a long-acting effect, the companies said today in a statement. Abilify currently is used daily.