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# Otsuka/H. Lundbeck sNDA for Rexulti in Adolescents
- URL: https://www.fdaweb.com/otsuka-h-lundbeck-snda-for-rexulti-in-adolescents/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150361

FDA has accepted for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in adolescents. Currently, Rexulti is approved for treating schizophrenia in adults and as an add-on treatment in adults with major depressive disorder in adults.

The submission is based on an extrapolation analysis using data from prior studies in adult patients, pharmacokinetic results from adult and pediatric trials, and six-month data from the ongoing open-label, long-term trial in adolescent schizophrenia patients (Trial 331-10-236), according to the companies. The safety profile is consistent of that observed in adult patients, they say, adding that the most common adverse events were somnolence (10.2%), and akathisia (2.4%).