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FDA approves ABILIFY for acute bipolar mania, including manic and mixed episodes.
2004 NOV 2 - (NewsRx.com & NewsRx.net) -- Bristol-Myers Squibb Co. (BMY) and Otsuka Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved ABILIFY (aripiprazole) for the treatment of acute bipolar mania, including manic and mixed episodes associated with bipolar disorder.
The FDA approval is based on positive results from 2 placebo-controlled, 3-week trials of 516 hospitalized patients with bipolar I disorder who were experiencing an acute manic or mixed episode.
In these studies, ABILIFY demonstrated significant improvement in the symptoms of acute manic or ...
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