Application 761411
- Type
- BLA
- Sponsor
- INCYTE CORP
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761411 | Niktimvo | axatilimab-csfr | 351(a) | Disc | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIKTIMVO | axatilimab-csfr | INJECTABLE;INTRAVENOUS | 50 MG/ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79627 | ORIG | 2024-09-16 |
| 79412 | ORIG | 2024-08-16 |
| 79398 | ORIG | 2024-08-14 |