Bristol-Myers Squibb (NYSE:BMY) announced that the U.S Food and Drug Administration has approved its drug Abilify for teens aged 13 - 17 that have been diagnosed with schizophrenia.
Abilify (aripiprazole) is an antipsychotic drug that was first approved by the FDA at the end of 2002 for adults with schizophrenia and since that time Bristol-Myers says that more than 12.5 million US prescriptions for the drug have been written.
"We are extremely pleased that ABILIFY, the first available dopamine partial agonist, is approved for the treatment of pediatric patients (13 to 17 years of age) suffering from schizophrenia," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "ABILIFY® (aripiprazole) offers an effective new option to help treat this serious mental illness."
"Schizophrenia is one of the most complex of all mental health disorders," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "We remain committed to providing innovative therapies, such as ABILIFY, to help patients, including adolescents, living with schizophrenia."
Extended approval was based on a six-week, double-blind, randomized, placebo controlled multi-center study involving 302 patients in 13 countries.
[Source: Bristol-Myers Squibb Press Release]
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» FDA Approves Abilify as Add-On for Major Depression from PharmaGazette
Earlier this month the U.S Food and Drug Administration approved Abilify for the treatment of schizophrenia in teens and have now expanded that approval to include patients with major depressive disorder.Approved in 2002 for schizophrenia in adult... [Read More]
Tracked on: November 23, 2007 9:42 AM | Permalink to Trackback