India, March 31 -- Vanda Pharmaceuticals Inc. (VNDA) announced Monday 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.
Bysanti is a new chemical entity that belongs in the class of atypical antipsychotic drugs. It is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors.
If approved, Bysanti could be available for sale in the US in 2026. ...