FDA Approves Expanded Indication for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Oct. 10, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (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 (BD-I) in adults. The approval is based on existing clinical data for UZEDY, coupled with Model-Informed Drug Development (MIDD) methodologies that leverage previous findings on the safety and efficacy of risperidone formulations already approved for BD-I.

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