FDA — authorised 2 July 2020
- Application: NDA212295
- Marketing authorisation holder: ACACIA
- Local brand name: BYFAVO
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Remimazolam infusion in United States
FDA authorised Remimazolam infusion on 2 July 2020
Marketing authorisations
FDA
- Status: approved
Remimazolam infusion in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Remimazolam infusion approved in United States?
Yes. FDA authorised it on 2 July 2020; FDA has authorised it.
Who is the marketing authorisation holder for Remimazolam infusion in United States?
ACACIA holds the US marketing authorisation.