Vanda Pharmaceuticals announces the submission of an NDA to the FDA for Bysanti for the treatments of acute bipolar I disorder and schizophrenia

Vanda Pharmaceuticals

31 March 2025 - Vanda Pharmaceuticals today announced that a new drug application was submitted to the US FDA requesting marketing approval of Bysanti (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. 

The new drug application is supported by several clinical studies assessing the efficacy and safety of Bysanti.

Read Vanda Pharmaceuticals press release 

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , US , Dossier