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  5. U.S. FDA Approves Labeling Update of REXULTI®(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.

September 26, 2016

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

U.S. FDA Approves Labeling Update of REXULTI®(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved the labeling update of REXULTI® (brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia in patients in the U.S. The approval was based on results from a long-term randomized withdrawal trial in adults with schizophrenia aged 18 to 65 years.

For additional information on the clinical trial results please refer to the announcement by OPDC here:


Information in this news release was current as of the original release date.

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