Prescription medicine
Clofarabine First approved as Clolar
Clofarabine (Clolar) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
Check it at the source: the clofarabine FDA label on DailyMed (effective December 12, 2022, Meitheal Pharmaceuticals Inc.); the NDA 21673 record on Drugs@FDA; every clofarabine label on DailyMed.
Highlights of the record
FDA label of December 12, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageClofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Forms and strengths
- 1 mg/ml
Injection.
On the market
- Earliest approval on file
- December 28, 2004 Clolar, Genzyme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 9, 2017; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest October 13, 2017
- FAERS reports
- 2,271 through July 30, 2026
What is clofarabine used for?
From the label: indications and usageClofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Conditions named in the indications of clofarabine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Clofarabine), Meitheal Pharmaceuticals Inc., effective December 12, 2022 (SPL set 54436453-882e-406b-87a3-049d150101c6), via openFDA; the full label on DailyMed
Is there a generic for clofarabine (Clolar)?
The FDA approved the first generic clofarabine on May 9, 2017. 12 generic applications are approved; 7 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists clofarabine from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2017 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has clofarabine been recalled?
The FDA's Enforcement Report lists 1 recall naming clofarabine since 2017: 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 |
|---|---|---|---|
| October 13, 2017 | Class III | Sanofi-Aventis U.S. LLC | Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clofarabine label say about other medicines?
The clofarabine label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name clofarabine. 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 |
|---|---|---|
| Cyclophosphamide | warnings and precautions | Disease of the Liver Patients who have previously received a hematopoietic stem cell transplant (HSCT) are at higher risk for veno-occlusive disease (VOD) of the liver following treatment with clofarabine (40 mg/m 2 ) when used in combination with etoposide (100 mg/m 2 ) and cyclophosphamide (440 mg/m 2 ). |
| Etoposide | warnings and precautions | Disease of the Liver Patients who have previously received a hematopoietic stem cell transplant (HSCT) are at higher risk for veno-occlusive disease (VOD) of the liver following treatment with clofarabine (40 mg/m 2 ) when used in combination with etoposide (100 mg/m 2 ) and cyclophosphamide (440 mg/m 2 ). |
| Hydrocortisone | warnings and precautions | The use of prophylactic steroids (e.g., 100 mg/m 2 hydrocortisone on Days 1 through 3) may be of benefit in preventing signs or symptoms of SIRS or capillary leak syndrome. |
Other labels that name clofarabine
Source: FDA drug label (Clofarabine), Meitheal Pharmaceuticals Inc., effective December 12, 2022 (SPL set 54436453-882e-406b-87a3-049d150101c6), via openFDA; the full label on DailyMed
What do FAERS reports show for clofarabine?
The FDA Adverse Event Reporting System holds 2,271 reports that list clofarabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 900 are coded as a death and 717 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 clofarabine?
36 other medicines are given the same way (intravenous) and in the same FDA class as clofarabine 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 |
|---|---|---|---|---|
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Fludarabine | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Cytarabine | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Cytarabine and daunorubicin | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pentostatin | Leukemia, lymphoma and myeloma | none listed | n/a | In shortage |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 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 |
Every medicine labeled for the same conditions as clofarabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to clofarabine
- 36 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Clofarabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other