Teva announces FDA approval of Uzedy for bipolar I disorder

Teva (TEVA) Pharmaceuticals announced that the Food and Drug Administration has approved Uzedy 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. Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to Medincell that controls the steady release of risperidone, Teva said in a statement. Uzedy was approved in the U.S. for the treatment of schizophrenia in adults in 2023.