FDA — authorised 22 March 2002
- Application: ANDA076264
- Marketing authorisation holder: SPECGX LLC
- Status: approved
🇺🇸 NALTREXONE in United States
FDA authorised NALTREXONE on 22 March 2002 · 5,171 US adverse-event reports
Marketing authorisations
FDA — authorised 21 April 2004
- Application: ANDA075274
- Marketing authorisation holder: ELITE LABS
- Indication: Labeling
- Status: approved
FDA — authorised 22 March 2010
- Application: NDA021897
- Marketing authorisation holder: ALKERMES
- Indication: Labeling
- Status: approved
FDA — authorised 22 July 2015
- Application: ANDA090356
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA207905
- Marketing authorisation holder: CHARTWELL
- Status: approved
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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 5,171
Most-reported reactions
- Fatigue — 724 reports (14%)
- Nausea — 712 reports (13.77%)
- Drug Ineffective — 682 reports (13.19%)
- Off Label Use — 543 reports (10.5%)
- Headache — 511 reports (9.88%)
- Pain — 510 reports (9.86%)
- Dizziness — 384 reports (7.43%)
- Insomnia — 372 reports (7.19%)
- Vomiting — 370 reports (7.16%)
- Diarrhoea — 363 reports (7.02%)
NALTREXONE 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 NALTREXONE approved in United States?
Yes. FDA authorised it on 22 March 2002; FDA authorised it on 21 April 2004; FDA authorised it on 22 March 2010.
Who is the marketing authorisation holder for NALTREXONE in United States?
SPECGX LLC holds the US marketing authorisation.