- FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.1
- UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults.1
- This approval marks a significant step towards addressing the unmet needs of people living with BD-I and schizophrenia, underscoring Teva’s ongoing commitment to drive new advances in neuroscience.2
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.
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.1 Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1 For the BD-I indication, UZEDY is now approved with three once-monthly dosing options (50 mg, 75 mg and 100 mg).
“Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help address existing unmet needs and treatment gaps,” said Chris Fox, Executive Vice President, U.S. Commercial at Teva. “This expanded indication for UZEDY builds on its success in adults living with schizophrenia and demonstrates Teva’s dedication to developing innovative medicines for complex mental health conditions that place a heavy burden on individuals and their caregivers.”
An estimated 1% (or 3,400,000+) of U.S. adults will develop BD-I in their lifetime which is associated with poor long-term outcomes and a substantial increase in mortality compared to the general population from both suicide and cardiovascular disease.3
“Bipolar I disorder carries profound implications for a person’s life and is linked to suboptimal long-term outcomes, with treatment adherence to daily oral options frequently presenting as a major impediment to effective care,” said Craig Chepke, MD, DFAPA, Medical Director, Excel Psychiatric Associates and Scientific Director, HMP Global’s Psych Congress events and programs. “The FDA’s decision to expand the indication for UZEDY may help those living with BD-I. As a clinician, I am excited to now have a new treatment option for this complex disease.”
UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023.2
“Long-acting injectables are increasingly recognized as key drivers of innovation in CNS therapeutics,” said Christophe Douat, CEO of Medincell. “We’re proud that UZEDY is now available to support patients living with bipolar I disorder. This milestone highlights the exceptional regulatory and commercial execution of our partner, Teva.”
The data reviewed by the FDA to support UZEDY’s approval for the treatment of BD-I includes the Agency’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BD-I as well as the efficacy, long-term safety and tolerability of UZEDY for the treatment of schizophrenia which was evaluated in two Phase 3 pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – Safety in Humans of TV-46000 sc INjection Evaluation).2
About Bipolar I Disorder
Bipolar I Disorder (BD-I) is a serious mental health condition defined by episodes of mania—periods of abnormally elevated or irritable mood with increased energy and activity—and often episodes of depression. These episodes can cause significant disruptions in thinking, behavior, and daily functioning. It is challenging to diagnose and is often accompanied by other psychiatric comorbidities. BD-I is associated with poor long-term outcomes and a substantial increase in mortality compared to the general population from both suicide and cardiovascular disease. An estimated 1% or 3,400,000+ of U.S. adults will develop BD-I in their lifetime.3
About UZEDY
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. In clinical trials, UZEDY significantly reduced the risk of schizophrenia relapse.1,2 UZEDY administers risperidone through copolymer technology under license from Medincell that allows for rapid absorption and sustained release after subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.1 For full prescribing information, visit https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.