The FDA has approved milsaperidone tablets (Bysanti) as first-line treatment for adults with schizophrenia and manic or mixed episodes of bipolar I disorder[2]. Vanda Pharmaceuticals has submitted a new drug application with a target date of February 21, 2026[1]. Bysanti is an atypical antipsychotic whose safety and efficacy are consistent with iloperidone[1]. The drug is based on the results of studies demonstrating the bioequivalence of Bysanti and iloperidone in both lower and higher doses[1]. If approved, it will be available for sale in the United States in 2026[1]. Bysanti is also being investigated in a phase three study as a potential adjunctive treatment for major depressive disorder in patients unresponsive to current treatment, with results expected in 2026[1].