FDA — authorised 8 February 2022
- Application: ANDA212955
- Marketing authorisation holder: PURDUE PHARMA LP
- Local brand name: NALMEFENE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
🇺🇸 Nalmefene HCl injection in United States
FDA authorised Nalmefene HCl injection on 8 February 2022
Marketing authorisations
FDA — authorised 22 May 2023
- Application: NDA217470
- Marketing authorisation holder: INDIVIOR
- Local brand name: OPVEE
- Indication: SPRAY — NASAL
- Status: approved
FDA — authorised 15 November 2023
- Application: ANDA216007
- Marketing authorisation holder: CHENGDU SHUODE
- Local brand name: NALMEFENE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
Frequently asked questions
Is Nalmefene HCl injection approved in United States?
Yes. FDA authorised it on 8 February 2022; FDA authorised it on 22 May 2023; FDA authorised it on 15 November 2023.
Who is the marketing authorisation holder for Nalmefene HCl injection in United States?
PURDUE PHARMA LP holds the US marketing authorisation.