Teva and Medincell Announce FDA Acceptance of Supplemental New Drug Application for UZEDY(R) (risperidone) Extended-Release Injectable Suspension as a Treatment for Patients with Bipolar I Disorder

Core Points - Teva Pharmaceuticals and Medincell announced the acceptance of the supplemental New Drug Application (sNDA) for UZEDY, an extended-release injectable suspension for the maintenance treatment of Bipolar I Disorder (BP-I) in adults by the FDA [1][2] - UZEDY has previously been approved for the treatment of schizophrenia and is expected to address nonadherence issues in BP-I treatment [3][4] - Teva will lead the regulatory process and commercialization efforts for UZEDY in the BP-I indication, while Medincell will receive royalties on net sales [3] Company Overview - Teva Pharmaceutical Industries Ltd. is a global pharmaceutical leader with a focus on innovation and the development of medicines across various therapeutic areas [34][35] - Medincell specializes in developing long-acting injectable drugs and has partnered with Teva for the commercialization of UZEDY [37] Product Information - UZEDY is indicated for the treatment of schizophrenia in adults and utilizes copolymer technology for sustained drug release [9][10] - The drug has shown efficacy in reducing the risk of schizophrenia relapse and is available in one- and two-month dosing intervals [9][10] - The safety and efficacy of UZEDY for BP-I are not yet established, as it is not approved for this indication [5]