Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 2026.
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone), an atypical antipsychotic for schizophrenia and manic or mixed episodes in bipolar I disorder. The drug will be available by the third quarter of 2026.
