Abilify Approved for Adolescents With Schizophrenia
TUESDAY, Nov. 6 -- The U.S. Food and Drug Administration has approved the Bristol-Myers Squibb antipsychotic drug Abilify (aripiprazole) for adolescents aged 13 to 17 diagnosed with schizophrenia, the company said Tuesday.
The FDA first approved the drug to treat schizophrenia in adults in November 2002. More than 12.5 million U.S. prescriptions for the medication have since been written, the drug maker said.
Expanded approval to teens was based on a six-week, 13-nation study that "demonstrated significant improvement with Abilify compared to placebo," a company statement said.
Abilify also is approved to treat acute manic or mixed episodes in people with bipolar I disorder.
Posted: November 2007