Biopharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq:VNDA) announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for BYSANTI (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.

BYSANTI is a new chemical entity (NCE) that belongs in the class of atypical antipsychotics.

According to Vanda, in clinical studies BYSANTI demonstrated bioequivalence to iloperidone across the therapeutic dosing spectrum, enabling it to leverage well-established knowledge of efficacy and safety derived from a rich clinical development program and more than 100,000 patient-years of real-world experience with Fanapt (iloperidone). As such BYSANTI represents a novel therapeutic option with a trusted safety profile in the treatment of these serious psychiatric conditions.

BYSANTI is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to complete by the end of this year.