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]

With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. "This first of its kind qualification by EMA regula ...