May 8, 2008 - 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 recommended starting and target dose of 15 mg daily for ABILIFY monotherapy in the treatment of Bipolar I Disorder in adults.
The details can be read here.
No comments:
Post a Comment