| | Country-specific information on aripiprazole
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The CPMP of the EMEA announced on 26 February 2004 that it has recommended EU approval of Otsuka's aripiprazole (Abilify) for the treatment of schizophrenia.
Otsuka is developing aripiprazole, a quinolinone derivative that acts as a postsynaptic dopamine D2 antagonist and a presynaptic dopamine D2 autoreceptor partial agonist, as a potential treatment for schizophrenia and bipolar disorder.
The product has been launched in the USA, Puerto Rico, Mexico, Brazil, and India, and is awaiting approval in Japan for the treatment of schizophrenia. A supplemental NDA has been submitted in the USA by licensee Bristol-Myers Squibb for the treatment of patients with bipolar disease. Committee for Proprietary Medicinal Products European Agency for the Evaluation of Medicinal Products new drug application new drug application new drug application
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