FDA — authorised 5 April 2022
- Application: NDA215390
- Marketing authorisation holder: BIOXCEL
- Local brand name: IGALMI
- Indication: FILM — BUCCAL, SUBLINGUAL
- Status: approved
🇺🇸 Dexmedetomidine Sublingual in United States
FDA authorised Dexmedetomidine Sublingual on 5 April 2022
Marketing authorisation
Other Neurology approved in United States
Frequently asked questions
Is Dexmedetomidine Sublingual approved in United States?
Yes. FDA authorised it on 5 April 2022.
Who is the marketing authorisation holder for Dexmedetomidine Sublingual in United States?
BIOXCEL holds the US marketing authorisation.