# DANYELZA (Naxitamab) by BTG International Inc.: new human prescription drug listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | DANYELZA |
| Generic name | Naxitamab |
| NDC | 50633-230 |
| Labeler | BTG International Inc. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | BLA |
| Application number | BLA761171 |
| Dosage form | INJECTION |
| Route | INTRAVENOUS |
| Active ingredients | NAXITAMAB 40 mg/10mL |
| Pharmacologic class | Glycolipid Disialoganglioside-directed Antibody [EPC] |
| Marketing start | 2026-09-01 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.
- Class: Glycolipid Disialoganglioside-directed Antibody [EPC].

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=50633-230). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.