Data updated: Nov 8, 2026
Bexxar (tositumomab and iodine i-131 tositumomab) · GSK
Approved 2003-06-27
1
Indication
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Disc
- First Approved
- 2003-06-27
- Routes
- Intravenous
- Dosage Forms
- Injection
Companies
Active Ingredient: tositumomab and iodine I-131 tositumomab , tositumomab and iodine I-131 tositumomab
Website: ↗
Bexxar Approval History
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2003 to 2003
Jun 2003 ORIGINAL
Update · CBER biologic (Purple Book)
What Bexxar Treats
1 FDA approvalsOriginally approved for its first indication in 2003 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2003)
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
BLUJEPA
2025 GEPOTIDACIN MESYLATE
2 designations
EXDENSUR
2025 DEPEMOKIMAB-ULAA
BLENREP
2025 BELANTAMAB MAFODOTIN-BLMF
5 designations
JESDUVROQ
2023 DAPRODUSTAT
1 designation
OJJAARA
2023 MOMELOTINIB DIHYDROCHLORIDE
1 designation
JEMPERLI
2021 DOSTARLIMAB-GXLY
3 designations
BREXAFEMME
2021 IBREXAFUNGERP CITRATE
3 designations
KRINTAFEL
2018 TAFENOQUINE SUCCINATE
3 designations
ZEJULA
2017 NIRAPARIB TOSYLATE
4 designations
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01389076 results posted | UMCC 2010.098 HUM00043235 | Ph 2 | terminated | Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Bexxar FDA Label Details
Track Bexxar with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.