Posted by Michael Wonder on 10 Oct 2025
FDA approves expanded indication for Uzedy (risperidone) extended release injectable suspension as a treatment for adults living with bipolar I disorder
10 October 2025 - Teva Pharmaceuticals announced today that the US FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
The approval is based on existing clinical data for Uzedy, coupled with model informed drug development methodologies that leverage previous findings on the safety and efficacy of risperidone formulations already approved for bipolar I disorder.
