FDA — authorised 23 May 2023
- Application: NDA210136
- Marketing authorisation holder: BRAEBURN
- Local brand name: BRIXADI
- Indication: SOLUTION, EXTENDED RELEASE — SUBCUTANEOUS
- Status: approved
🇺🇸 Injectable buprenorphine in United States
FDA authorised Injectable buprenorphine on 23 May 2023
Marketing authorisation
Other Psychiatry / Addiction Medicine approved in United States
Frequently asked questions
Is Injectable buprenorphine approved in United States?
Yes. FDA authorised it on 23 May 2023.
Who is the marketing authorisation holder for Injectable buprenorphine in United States?
BRAEBURN holds the US marketing authorisation.