Quick answers
- What is Naxitamab used for?
- The FDA-approved label (Danyelza, BTG International Inc., August 7, 2026) says: “DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Naxitamab have a boxed warning?
- Yes. The FDA label for Danyelza has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Naxitamab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Naxitamab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Naxitamab?
- 1 company lists prescription products of Naxitamab in the FDA NDC Directory, including BTG International Inc.
What Naxitamab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. …
— FDA label: Danyelza, BTG International Inc., effective August 7, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Danyelza |
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.
- BTG International Inc1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761171 DANYELZA | Y-Mabs Therapeutics Inc | November 25, 2020 | 2, latest August 27, 2025 2025: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2474239, 2474244 |
|---|---|
| SPL set ID of the quoted label | b0f5ee96-369f-4cb9-a783-3bfa70fe8f90 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761171 |
| Active ingredients (FDA) | NAXITAMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Danyelza, BTG International Inc., effective August 7, 2026; 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 →