Bysanti (milsaperidone) PDUFA Date (Vanda Pharmaceuticals)

Name: FDA PDUFA Decision: Bysanti (milsaperidone)
Start: 2026-02-20

FDA PDUFA decision date for Bysanti (milsaperidone) is February 20, 2026. Developed by Vanda Pharmaceuticals. Indication: Schizophrenia and Bipolar I disorder. Current status: Approved.

Indication

Schizophrenia and Bipolar I disorder

Regulatory details

Company: Vanda Pharmaceuticals
Therapeutic area: Psychiatry / CNS
Application type: NDA
Review type: Standard
PDUFA date: 2026-02-20
Outcome: Approved

Bysanti (milsaperidone) PDUFA Date — Vanda Pharmaceuticals