FDA — authorised 11 October 2013
- Application: NDA204824
- Marketing authorisation holder: ASSERTIO SPECLTY
- Local brand name: OTREXUP PFS
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 MTX in United States
FDA authorised MTX on 11 October 2013 · 2,981 US adverse-event reports
Marketing authorisations
FDA — authorised 27 November 2019
- Application: NDA210737
- Marketing authorisation holder: NORDIC GRP
- Local brand name: REDITREX
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 29 November 2022
- Application: NDA212479
- Marketing authorisation holder: SHORLA
- Local brand name: JYLAMVO
- Indication: SOLUTION — ORAL
- 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: 22 April 2025 – 22 April 2026
- Total reports: 2,981
Most-reported reactions
- Drug Ineffective — 581 reports (19.49%)
- Arthralgia — 384 reports (12.88%)
- Rheumatoid Arthritis — 371 reports (12.45%)
- Nausea — 306 reports (10.27%)
- Pain — 293 reports (9.83%)
- Fatigue — 286 reports (9.59%)
- Pneumonia — 202 reports (6.78%)
- Headache — 197 reports (6.61%)
- Pain In Extremity — 188 reports (6.31%)
- Drug Effect Decreased — 173 reports (5.8%)
Other Oncology approved in United States
Frequently asked questions
Is MTX approved in United States?
Yes. FDA authorised it on 11 October 2013; FDA authorised it on 27 November 2019; FDA authorised it on 29 November 2022.
Who is the marketing authorisation holder for MTX in United States?
ASSERTIO SPECLTY holds the US marketing authorisation.