India Pharma Outlook Team | Saturday, 11 October 2025
Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries, announced that the U.S. Food and Drug Administration have approved UZEDY (risperidone).
It is an extended-release injection to be administered once-monthly, for maintenance treatment of bipolar I disorder (BD-I) in adults. The therapy may be used as monotherapy or as an adjunctive treatment with lithium or valproate.
The FDA approval of UZEDY is based on the existing clinical data augmented with Model-Informed Drug Development (MIDD) methodologies, which leverage previous results of safety and efficacy from risperidone formulations for BD-I.
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“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.
“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.
This development represents a significant advancement of long-acting psychiatric medications and a new indication for UZEDY following its 2023 approval for schizophrenia.
UZEDY is the first subcutaneous long-acting formulation of risperidone that utilizes Medincell’s proprietary SteadyTeq technology, a copolymer platform that governs a steady and controlled release of drug. Therapeutic blood levels are achieved within 6-24 hours following a single dose. UZEDY is available in three once-monthly dosing options — 50 mg, 75 mg, and 100 mg.
