Application 761134
- Type
- BLA
- Sponsor
- EVIVE BIOTECHNOLOGY
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761134 | Ryzneuta | efbemalenograstim alfa-vuxw | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYZNEUTA | EFBEMALENOGRASTIM ALFA-VUXW | INJECTABLE;INJECTION | 20MG/ML | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RYZNEUTA | EFBEMALENOGRASTIM ALFA-VUXW | Acrotech Biopharma Inc | 290ed754-758c-9cae-e063-6294a90ae68b | 2026-05-19 | Warnings, Adverse reactions | BLA761134 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.