Quick answers
- What is Nelarabine used for?
- The FDA-approved label (Arranon, Sandoz Inc, March 31, 2025) says: “ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nelarabine have a boxed warning?
- Yes. The FDA label for Arranon has a boxed warning (“WARNING: NEUROLOGIC ADVERSE REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Nelarabine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nelarabine been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nelarabine?
- 13 companies list prescription products of Nelarabine in the FDA NDC Directory, including Shorla Oncology Inc., Zydus Pharmaceuticals USA Inc. and Novadoz Pharmaceuticals LLC.
What Nelarabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. …
— FDA label: Arranon, Sandoz Inc, effective March 31, 2025. Read the full label on DailyMed →
The FDA has 13 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: NEUROLOGIC ADVERSE REACTIONS
. Read it on the full label →
12 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Arranon |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Shorla Oncology Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Novadoz Pharmaceuticals LLC1 product
- Sagent Pharmaceuticals1 product
- Amneal Pharmaceuticals LLC1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
- Alembic Pharmaceuticals Limited1 product
- Zydus Lifesciences Limited1 product
- Dr. Reddy's Laboratories Inc.1 product
- Gland Pharma Limited1 product
- Sandoz Inc1 product
- Alembic Pharmaceuticals Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021877 ARRANON | Sandoz | October 28, 2005 | 9, latest March 11, 2025 2025: Labeling · 2019: Manufacturing (CMC) · 2019: Efficacy |
Generic approvals (9)
- ANDA215037Zydus Pharms · November 17, 2021
- ANDA216934DR Reddys · December 22, 2022
- ANDA216038Meitheal · January 10, 2023
- ANDA214809Shorla · March 3, 2023
- ANDA216346Amneal · April 4, 2023
- ANDA212605Gland · January 3, 2024
- ANDA218554Alembic · August 1, 2024
- ANDA216510Pharmobedient · September 5, 2024
- ANDA216948Msn · September 13, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 13, 2025 · Class II · Ongoing · D-0256-2025
Failed Impurities/Degradation Specifications
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Di — Zydus Pharmaceuticals (USA) Inc
-
February 13, 2025 · Class II · Ongoing · D-0255-2025
Failed Impurities/Degradation Specifications
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Di — Zydus Pharmaceuticals (USA) Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 603566, 616366, 2722411 |
|---|---|
| SPL set ID of the quoted label | 0f9051de-5c4d-4c0f-8c19-e15214498cca |
| FDA labels (SPL) | 13 |
| FDA applications | NDA021877, 9 ANDA |
| Active ingredients (FDA) | NELARABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Arranon, Sandoz Inc, effective March 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →