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Treats indolent B-cell non-Hodgkin lymphoma. Sold as Treanda, Belrapzo, Bendeka, Bendamustine Hydrochloride, Vivimusta and 1 more. Every FDA application for this active ingredient: 10 branded and 11 generic.
As of Nov 15, 2026, FDA lists 21 applications for Bendamustine Hydrochloride (sold as Treanda, Belrapzo, Bendeka and others), first approved Mar 20, 2008, with 0 new uses approved and 0 published complete response letters.
First approved: Mar 20, 2008
Applications: 21
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $83.0M
First approved in Japan: Oct 27, 2010
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 31 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
TreakisymA drug with a new dosage indicated for the treatment of low-grade B-cell non-Hodgkin’s lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, and… · SymBio Pharmaceuticals Limited · Feb 25, 2022
TreakisymDrugs with a new indication and a new dosage for the treatment of relapsed or refractory diffuse large B-cell lymphoma. · SymBio Pharmaceuticals Limited · Mar 23, 2021
TreakisymDrugs with other characteristics indicated for the treatment prior to tumor-specific T-cell infusion therapy. · SymBio Pharmaceuticals Limited · Mar 26, 2019
TreakisymDrugs with a new dosage indicated for the treatment of low-grade B-cell non-Hodgkin’s lymphoma. · SymBio Pharmaceuticals Limited · Jul 2, 2018
TreakisymDrugs with a revised indication and a new dosage for the treatment of low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma. · SymBio Pharmaceuticals Ltd. · Dec 19, 2016 · Review report
Treakisym, new approvalA drug with a new additional indication, dosage, and dosage form for the treatment of chronic lymphocytic leukemia. · SymBio Pharmaceuticals Limited · Sep 28, 2016
TreakisymA drug with a new additional indication and a new dosage for the treatment of chronic lymphocytic leukemia. · SymBio Pharmaceuticals Limited · Aug 26, 2016
Treakisym, new ingredientA drug with a new active ingredient indicated for the treatment of relapsed or refractory indolent B- cell non-Hodgkin’s lymphoma and mantle cell lymphoma. · SymBio Pharmaceuticals Limited · Oct 27, 2010
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
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Fresenius Kabi USA