The label establishes pediatric indications for schizophrenia at ages 13–17, bipolar mania at ages 10–17, autism-associated irritability at ages 6–17, and Tourette’s disorder, with pediatric Tourette’s trials totaling 194 participants. It does not establish pediatric safety and effectiveness for major depressive disorder or agitation associated with schizophrenia or bipolar mania.
Safety and effectiveness in pediatric patients with major depressive disorder or agitation associated with schizophrenia or bipolar mania have not been established.
The label establishes pediatric indications for schizophrenia at ages 13–17, bipolar mania at ages 10–17, autism-associated irritability at ages 6–17, and Tourette’s disorder, with pediatric Tourette’s trials totaling 194 participants. It does not establish pediatric safety and effectiveness for major depressive disorder or agitation associated with schizophrenia or bipolar mania.