On this page
Elahere
mirvetuximab soravtansine-gynx
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Elahere
Proper name
mirvetuximab soravtansine-gynx
Licence type
351(a)
BLA number
761310
Applicant
ImmunoGen, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/20ML (5MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | November 14, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 14, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |