FDA Approves Expanded Indication for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder

Core Insights - Teva Pharmaceuticals and Medincell announced FDA approval for UZEDY® (risperidone) as a once-monthly extended-release injectable for the maintenance treatment of bipolar I disorder (BD-I) in adults, addressing unmet needs in mental health treatment [1][3][4] - UZEDY is the first subcutaneous long-acting formulation of risperidone, utilizing proprietary SteadyTeq™ technology for controlled release [2][5] - The approval is based on existing clinical data and Model-Informed Drug Development (MIDD) methodologies, leveraging previous findings on risperidone's safety and efficacy [1][3] Company Overview - Teva Pharmaceutical Industries Ltd. is a leading biopharmaceutical company with a strong commitment to neuroscience and innovative medicines, having over 120 years of experience [12] - Medincell is a biopharmaceutical licensing company focused on developing long-acting injectable drugs, with proprietary BEPO® technology for controlled drug delivery [17] Product Details - UZEDY is now approved with three dosing options: 50 mg, 75 mg, and 100 mg, and is indicated for use as monotherapy or adjunctive therapy to lithium or valproate [2][5] - The product was previously approved for the treatment of schizophrenia in adults in 2023, highlighting its versatility in treating complex mental health conditions [3][4] Market Impact - An estimated 1% of U.S. adults (over 3.4 million) will develop BD-I in their lifetime, indicating a significant market opportunity for UZEDY [3][5] - The introduction of long-acting injectables like UZEDY is seen as a key driver of innovation in central nervous system (CNS) therapeutics, potentially improving treatment adherence and outcomes for patients [3][4]