Application 761310
- Type
- BLA
- Sponsor
- IMMUNOGEN INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761310 | Elahere | mirvetuximab soravtansine-gynx | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRVETUXIMAB SORAVTANSINE | MIRVETUXIMAB SORAVTANSINE | INJECTABLE;INJECTION | 100mg/20mL single-dose vial | 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 |
|---|---|---|---|---|---|---|
| ELAHERE | MIRVETUXIMAB SORAVTANSINE | ImmunoGen, Inc. | 00c424b5-6ccd-48ab-9e88-1986451120e2 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | BLA761310 72903-853 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72903-853 | ELAHERE | mirvetuximab soravtansine | ImmunoGen, Inc. | BLA | Current |