Drug profile · INN
gemtuzumab ozogamicin
MYLOTARG
gemtuzumab ozogamicin (MYLOTARG) is a myeloid cell surface antigen cd33 binding agent. Associated with Pfizer Australia Pty Ltd. Route of administration: single-dose. Current US regulatory status: approved.
Drug details — gemtuzumab ozogamicin
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- SINGLE-DOSE
- Patents
- 0
- Programs
- 4
- Data quality
- 0.84
Quick answer
gemtuzumab ozogamicin (MYLOTARG) is a myeloid cell surface antigen cd33 binding agent. Associated with Pfizer Australia Pty Ltd. Route of administration: single-dose. Current US regulatory status: approved.
Key facts
Mechanism of action
Myeloid cell surface antigen CD33 binding agent
Primary target: DNA
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is gemtuzumab ozogamicin?
gemtuzumab ozogamicin (MYLOTARG) is a myeloid cell surface antigen cd33 binding agent. Associated with Pfizer Australia Pty Ltd. Route of administration: single-dose. Current US regulatory status: approved.
What is the brand name for gemtuzumab ozogamicin?
MYLOTARG is a marketed brand name for gemtuzumab ozogamicin. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of gemtuzumab ozogamicin?
gemtuzumab ozogamicin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.