Quick answers
- What is Gemtuzumab ozogamicin used for?
- The FDA-approved label (Mylotarg, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., December 19, 2025) says: “MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gemtuzumab ozogamicin have a boxed warning?
- Yes. The FDA label for Mylotarg has a boxed warning (“WARNING: HEPATOTOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Gemtuzumab ozogamicin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gemtuzumab ozogamicin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Gemtuzumab ozogamicin?
- 1 company lists prescription products of Gemtuzumab ozogamicin in the FDA NDC Directory, including Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..
What Gemtuzumab ozogamicin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MYLOTARG is a CD33-directed antibody and cytotoxic drug conjugate indicated for: • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older. • treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older. …
— FDA label: Mylotarg, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective December 19, 2025. 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.
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: HEPATOTOXICITY
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Mylotarg |
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.
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761060 MYLOTARG | Wyeth Pharms Inc | September 1, 2017 | 3, latest June 16, 2020 2020: Efficacy · 2020: Labeling · 2018: 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) | 1944701, 1944704 |
|---|---|
| SPL set ID of the quoted label | 32fd2bb2-1cfa-4250-feb8-d7956c794e05 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761060 |
| Active ingredients (FDA) | GEMTUZUMAB OZOGAMICIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Mylotarg, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective December 19, 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 →