The U.S. FDA has expanded the indication for Teva Pharmaceutical Industries’ (NYSE:TEVA) long-acting atypical antipsychotic Uzedy (risperidone) as monotherapy or adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder.
Uzedy is given via subcutaneous injection once a month for the new indication. It was already used for schizophrenia.
Approval was based on the FDA’s previous evaluation of prior risperidone formulations approved for bipolar disorder as well as two phase 3 studies for Uzedy for schizophrenia.
