Teva Pharmaceutical Receives FDA Approval to Expand UZEDY Indication for Maintenance Treatment of Bipolar I Disorder

Core Insights - Teva Pharmaceutical Industries Limited has received FDA approval for an expanded indication of UZEDY for the maintenance treatment of bipolar I disorder (BD-I) in adults [1][3] - UZEDY is a long-acting formulation of risperidone that utilizes proprietary technology to control the steady release of the medication, reaching therapeutic blood concentrations within 6-24 hours [2] Product Details - UZEDY is now approved with three once-monthly dosing options: 50 mg, 75 mg, and 100 mg for the newly approved BD-I indication [3] - The drug was previously approved for the treatment of schizophrenia in adults, with dosing options available every one or two months [3] Market Context - BD-I affects an estimated 1% of US adults, translating to over 3.4 million individuals, highlighting the significant unmet needs in this patient population [2] - Teva operates in the development, manufacturing, marketing, and distribution of generic and biopharmaceutical products across various regions including the US, Europe, and Israel [4]