Article: U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Add-On Treatment to Lithium or Valproate in the Acute Treatment of Adults With Manic and Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features.

PRINCETON, N.J. & TOKYO -- Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved updated labeling for ABILIFY([R]) (aripiprazole) as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults. ABILIFY has been approved as monotherapy for the treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004.

In addition to this new indication, the FDA also approved a new ...

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