Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Sold as Rituxan. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Rituximab (sold as Rituxan), first approved Nov 26, 1997, with 17 new uses approved and 0 published complete response letters.
First approved: Nov 26, 1997
Applications: 1
New uses approved: 17
Complete response letters: 0
Medicare spending, 2025: $497M
Orphan exclusivity until: Dec 2, 2028
First approved in the EU: Jun 2, 1998
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
RituxanDrugs with a new indication and a new dosage for the treatment of autoimmune hemolytic anemia. · Zenyaku Kogyo Co., Ltd. · Feb 19, 2026
RituxanDrugs with a new indication and a new dosage for the treatment of nephrotic syndrome (frequently relapsing or steroid-dependent nephrotic syndrome). · Zenyaku Kogyo Co., Ltd. · Mar 27, 2025
RituxanDrugs with a new additional pediatric dosage indicated for the treatment of chronic idiopathic thrombocytopenic purpura. · Zenyaku Kogyo Co., Ltd. · Nov 22, 2024
RituxanDrugs with a new indication and a new dosage for the treatment of refractory nephrotic syndrome (for use steroid-resistant nephrotic syndrome). · Zenyaku Kogyo Co., Ltd. · Sep 24, 2024
RituxanDrugs with a new indication and a new dosage for the suppression of antibody-mediated rejection in the following organ transplantations: kidney… · Zenyaku Kogyo Co., Ltd. · Dec 22, 2023
RituxanDrugs with a new indication and a new dosage for the treatment of lupus nephritis in patients who have not responded sufficiently to conventional treatments. · Zenyaku Kogyo Co., Ltd. · Aug 23, 2023
RituxanDrugs with a new indication and a new dosage for the prevention of relapse of neuromyelitis optica spectrum disorder (including neuromyelitis optica). · Zenyaku Kogyo Co., Ltd. · Jun 20, 2022 · Review report
RituxanDrugs with a new indication and a new dosage for the treatment of refractory pemphigus vulgaris and pemphigus foliaceus. · Zenyaku Kogyo Co., Ltd. · Dec 24, 2021
Clinical Trials
700 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA