October 10, 2025
1 min read
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA approved extended-release Uzedy for the maintenance treatment of adults with bipolar I disorder, according to a press release from Teva Pharmaceuticals.
The FDA approved extended-release Uzedy for the maintenance treatment of adults with bipolar I disorder.
As Healio previously reported, the FDA approved Uzedy (risperidone, Teva Pharmaceuticals, MedinCell) for the treatment of schizophrenia in 2023.
The expanded indication is specifically for subcutaneous use as a once-monthly extended-release injectable suspension (50 mg, 75 mg or 100 mg) and can be administered as monotherapy or as adjunctive therapy to lithium or valproate, according to the release.
Teva stated that existing clinical data for Uzedy, as well as model-informed drug development methodologies leveraging past findings on the safety and efficacy of risperidone formulations already approved for bipolar I disorder, formed the basis of this approval.
“Adults living with [bipolar I disorder] 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,” Chris Fox, executive vice president, U.S. Commercial at Teva, said in the release.
“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,” Fox said.
