FDA — authorised 20 February 2026
- Application: NDA220358
- Marketing authorisation holder: VANDA PHARMS INC
- Local brand name: BYSANTI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Milsaperidone in United States
FDA authorised Milsaperidone on 20 February 2026
Marketing authorisations
FDA
- Status: approved
Milsaperidone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Milsaperidone approved in United States?
Yes. FDA authorised it on 20 February 2026; FDA has authorised it.
Who is the marketing authorisation holder for Milsaperidone in United States?
VANDA PHARMS INC holds the US marketing authorisation.