Overview

• The approval covers adult maintenance therapy as monotherapy or as an adjunct to lithium or valproate.
• The label specifies once‑monthly subcutaneous doses of 50 mg, 75 mg, or 100 mg.
• FDA reviewers incorporated findings from earlier risperidone formulations along with UZEDY’s schizophrenia data using model‑informed drug development methods.
• UZEDY is the first long‑acting subcutaneous risperidone using Medincell’s SteadyTeq technology and reaches therapeutic levels within 6–24 hours.
• The prescribing information includes boxed warnings for increased mortality in elderly patients with dementia‑related psychosis, neuroleptic malignant syndrome, and tardive dyskinesia.