Vanda Pharmaceuticals announced FDA approval for BYSANTI™ (milsaperidone) as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults. The drug is expected to be commercially available in Q3 2026 and comes with patent protection until 2044. BYSANTI™ is also undergoing further clinical study as an adjunctive treatment for treatment-resistant major depressive disorder.
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Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
Vanda Pharmaceuticals announced FDA approval for BYSANTI™ (milsaperidone) as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults. The drug is expected to be commercially available in Q3 2026 and comes with patent protection until 2044. BYSANTI™ is also undergoing further clinical study as an adjunctive treatment for treatment-resistant major depressive disorder.