FDA — authorised 20 December 1996
- Application: NDA020622
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: COPAXONE
- Indication: FOR SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Copaxone in United States
FDA authorised Copaxone on 20 December 1996 · 28,119 US adverse-event reports
Marketing authorisations
FDA — authorised 16 April 2015
- Application: ANDA090218
- Marketing authorisation holder: SANDOZ
- Local brand name: GLATOPA
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 25 September 2024
- Application: ANDA206873
- Marketing authorisation holder: SYNTHON PHARMS INC
- Local brand name: GLATIRAMER ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 31 December 2025
- Application: ANDA214741
- Marketing authorisation holder: SCINOPHARM TAIWAN
- Local brand name: GLATIRAMER ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 11 February 2026
- Application: ANDA214022
- Marketing authorisation holder: HYBIO
- Local brand name: GLATIRAMER ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
The FDA approved HYBIO's application (ANDA214022) for GLATIRAMER ACETATE (Copaxone) on 11 February 2026. This approval allows HYBIO to market the drug for subcutaneous injection. GLATIRAMER ACETATE is a treatment for a specified indication, as per the approved application.
FDA
- 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: 28,119
Most-reported reactions
- Multiple Sclerosis Relapse — 4,599 reports (16.36%)
- Drug Ineffective — 3,395 reports (12.07%)
- Injection Site Pain — 3,306 reports (11.76%)
- Injection Site Reaction — 3,003 reports (10.68%)
- Fatigue — 2,905 reports (10.33%)
- Dyspnoea — 2,501 reports (8.89%)
- Multiple Sclerosis — 2,479 reports (8.82%)
- Fall — 2,316 reports (8.24%)
- Gait Disturbance — 1,906 reports (6.78%)
- Pain — 1,709 reports (6.08%)
Copaxone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Copaxone approved in United States?
Yes. FDA authorised it on 20 December 1996; FDA authorised it on 16 April 2015; FDA authorised it on 25 September 2024.
Who is the marketing authorisation holder for Copaxone in United States?
TEVA PHARMS USA holds the US marketing authorisation.