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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