FDA — authorised 6 July 2023
- Application: ANDA213195
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: NALTREXONE
- Indication: FOR SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
- Status: approved
🇺🇸 Pharmacotherapy for opioid use disorder in United States
FDA authorised Pharmacotherapy for opioid use disorder on 6 July 2023
Marketing authorisations
FDA
- Status: approved
Pharmacotherapy for opioid use disorder 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 Pharmacotherapy for opioid use disorder approved in United States?
Yes. FDA authorised it on 6 July 2023; FDA has authorised it.
Who is the marketing authorisation holder for Pharmacotherapy for opioid use disorder in United States?
TEVA PHARMS USA INC holds the US marketing authorisation.