FDA Expands UZEDY Approval to Bipolar I Disorder

Paris: The FDA has approved UZEDY, the first subcutaneous long-acting risperidone formulation utilizing SteadyTeq™ technology, for maintenance treatment of bipolar l disorder-broadening its use beyond schizophrenia .

UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that controls the steady release of risperidone .1 Therapeutic blood concentrations are reached within 6-24 hours of a single dose.1 For the BD-I indication, UZEDY is now approved with three once-monthly dosing options (50 mg, 75 mg and 100 mg).

“Adults living with BD-I experience debilitating manic and depressive symptoms, and today’s FDA approval of UZEDY provides a new long-acting formulation of risperidone that may help a