
Vanda Submits New Drug Application to FDA for Bysanti™ to Treat Bipolar I Disorder and Schizophrenia
WASHINGTON, March 31, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.