Prescription medicine
Bendamustine Brand names: Treanda, Vivimusta, Gobarden, Belrapzo, Bendeka
Bendamustine (Vivimusta) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the bendamustine FDA label on DailyMed (effective May 11, 2026, Meitheal Pharmaceuticals Inc.); the NDA 22249 record on Drugs@FDA; every bendamustine label on DailyMed.
Highlights of the record
FDA label of May 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBendamustine Hydrochloride for Injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL).
Forms and strengths
- 100 mg
- 25 mg/5ml
- 25 mg/ml
- 100 mg/20ml
- 100 mg/4ml
Injection (powder) (lyophilized) for solution; injection; injection (solution).
On the market
- Earliest approval on file
- March 20, 2008 Treanda, Cephalon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first December 7, 2022; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 4 under generic applications, 8 under brand applications, repackagers included
- Last listed patent
- July 29, 2042 Vivimusta injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest August 14, 2023
- FAERS reports
- 23,763 through July 30, 2026
What is bendamustine used for?
From the label: indications and usageBendamustine Hydrochloride for Injection is an alkylating drug indicated for treatment of patients with: Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) Bendamustine Hydrochloride for Injection is indicated for the treatment of patients with chronic lymphocytic leukemia. […]
Conditions named in the indications of bendamustine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Bendamustine), Meitheal Pharmaceuticals Inc., effective May 11, 2026 (SPL set 40f6f58d-d9ac-4f65-9fc7-16984bf1f180), via openFDA; the full label on DailyMed
Is there a generic for bendamustine (Vivimusta)?
The FDA approved the first generic bendamustine on December 7, 2022. 8 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists bendamustine from 4 labelers under a generic (ANDA) application and from 8 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Vivimusta injection, the last expiring on July 29, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2022 first generic approved
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is bendamustine in shortage?
No bendamustine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated July 23, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Treanda, Injection, Solution, 25 mg/5 mL, 1 vial, Single-Dose in 1 carton (NDC 63459-390-08) | Cephalon, LLC (a wholly owned subsidiary of Teva Pharmaceutical Industries, Ltd.) | To Be Discontinued | July 23, 2026 |
Every bendamustine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has bendamustine been recalled?
The FDA's Enforcement Report lists 1 recall naming bendamustine since 2023: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 14, 2023 | Class III | Baxter Healthcare Corporation | Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bendamustine label say about other medicines?
The bendamustine label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name bendamustine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | warnings and precautions | However, there may be an increased risk of severe skin toxicity when bendamustine hydrochloride and allopurinol are administered concomitantly [see Warnings and Precautions ( 5.6 )]. |
| Dehydrated alcohol | contraindications | CONTRAINDICATIONS VIVIMUSTA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol [see Warnings and Precautions ( 5.4 )] History of a hypersensitivity reaction to bendamustine … |
| Obinutuzumab | warnings and precautions | Leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), including fatal cases, have occurred following treatment with bendamustine, primarily in combination with rituximab or obinutuzumab [see Adverse Reactions ( 6.2 )]. |
| Rituximab | warnings and precautions | Leukoencephalopathy (PML) Progressive multifocal leukoencephalopathy (PML), including fatal cases, have occurred following treatment with bendamustine, primarily in combination with rituximab or obinutuzumab [see Adverse Reactions ( 6.2 )]. |
Source: FDA drug label (Bendamustine), Meitheal Pharmaceuticals Inc., effective May 11, 2026 (SPL set 40f6f58d-d9ac-4f65-9fc7-16984bf1f180), via openFDA; the full label on DailyMed
What do FAERS reports show for bendamustine?
The FDA Adverse Event Reporting System holds 23,763 reports that list bendamustine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,908 are coded as a death and 9,072 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bendamustine?
36 other medicines are given the same way (intravenous) and in the same FDA class as bendamustine or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Melphalan | Leukemia, lymphoma and myeloma | 6 labelers | n/a | A presentation being discontinued |
| Carmustine | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as bendamustine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to bendamustine
- 36 medicines for the same use
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Bendamustine side effects
- the label's list beside FAERS reports
- Bendamustine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other