Teva Pharmaceuticals and Medincell have gained approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone), a once-a-month extended-release injectable suspension to treat adult patients with bipolar I disorder (BD-I).
The medication has been approved for use as a standalone treatment or as an addition to lithium or valproate therapies for maintenance treatment of the disorder.
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The US regulator’s clearance for Uzedy is supported by a combination of current clinical data and model-informed drug development (MIDD) techniques.
These methods capitalise on the established efficacy and safety profiles of previously approved risperidone formulations indicated for BD-I.
The agency also considered Uzedy’s tolerability, efficacy and extended safety data in schizophrenia treatment, substantiated by the pivotal Phase III RISE and SHINE studies.
Uzedy received FDA approval in 2023 to treat schizophrenia in adults.
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By GlobalDataTeva US Commercial executive vice-president Chris Fox stated: “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.
“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.”
Uzedy is a long-acting risperidone formula, incorporating Medincell’s copolymer technology, SteadyTeq, which ensures a consistent release of the medication.
Therapeutic blood levels are achieved within six to 24 hours following a single administration.
With the FDA’s approval, Uzedy now offers three monthly dosing options for BD-I patients: 50mg, 75mg and 100mg.
In August 2025, Teva’s Ajovy received the agency’s approval for label expansion, marking it as the first migraine prevention medication for specific paediatric groups.
