Parsippany, N.J. and Tel Aviv, Israel and Paris — October 10, 2025 — Leads & Copy — Teva Pharmaceuticals and Medincell announced 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.
UZEDY, a subcutaneous, long-acting formulation of risperidone using Medincell’s SteadyTeq™ technology, reaches therapeutic blood concentrations within 6-24 hours of a single dose. It is now approved with three once-monthly dosing options (50 mg, 75 mg, and 100 mg) for BD-I.
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.
Chris Fox, Executive Vice President, U.S. Commercial at Teva, stated that the approval provides a new long-acting formulation of risperidone that may help address unmet needs and treatment gaps for adults with BD-I, building on its success in schizophrenia treatment.
Craig Chepke, MD, DFAPA, Medical Director, Excel Psychiatric Associates and Scientific Director, HMP Global’s Psych Congress events and programs, noted that the FDA’s decision may help those living with BD-I, offering a new treatment option for this complex disease.
Christophe Douat, CEO of Medincell, said they are proud that UZEDY is now available to support patients with bipolar I disorder and highlighted the exceptional regulatory and commercial execution of their partner, Teva.
UZEDY was previously approved in the U.S. for treating schizophrenia in adults in 2023.
Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries: TevaIR@tevapharm.com
Contact Medincell: communication@medincell.com
Source: Teva Pharmaceutical Industries Ltd.
