FDA — authorised 28 November 2018
- Application: BLA761088
- Marketing authorisation holder: CELLTRION INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 RITUXIMAB in United States
FDA authorised RITUXIMAB on 28 November 2018 · 158,246 US adverse-event reports
Marketing authorisations
FDA — authorised 17 December 2020
- Application: BLA761140
- Marketing authorisation holder: AMGEN INC
- Status: approved
FDA — authorised 10 June 2021
- Application: BLA761064
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2021
- Application: BLA103705
- Marketing authorisation holder: GENENTECH
- Indication: Labeling
- Status: approved
FDA — authorised 9 June 2025
- Application: BLA761103
- Marketing authorisation holder: PFIZER INC
- 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: 158,246
Most-reported reactions
- Off Label Use — 34,114 reports (21.56%)
- Drug Ineffective — 27,080 reports (17.11%)
- Rheumatoid Arthritis — 16,092 reports (10.17%)
- Pain — 14,147 reports (8.94%)
- Fatigue — 13,509 reports (8.54%)
- Pneumonia — 11,328 reports (7.16%)
- Rash — 10,812 reports (6.83%)
- Arthralgia — 10,755 reports (6.8%)
- Drug Intolerance — 10,214 reports (6.45%)
- Infusion Related Reaction — 10,195 reports (6.44%)
RITUXIMAB 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 RITUXIMAB approved in United States?
Yes. FDA authorised it on 28 November 2018; FDA authorised it on 17 December 2020; FDA authorised it on 10 June 2021.
Who is the marketing authorisation holder for RITUXIMAB in United States?
CELLTRION INC holds the US marketing authorisation.