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Hemlibra
emicizumab-kxwh
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hemlibra
Proper name
emicizumab-kxwh
Licence type
351(a)
BLA number
761083
Applicant
Genentech, Inc.
Center
CDER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 105MG/0.7ML | Injection | Subcutaneous | Single-Dose Vial | Rx | November 16, 2017 |
| 12MG/0.4ML | Injection | Subcutaneous | Single-Dose Vial | Rx | January 31, 2024 |
| 150MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | November 16, 2017 |
| 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | March 16, 2023 |
| 30MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | November 16, 2017 |
| 60MG/0.4ML | Injection | Subcutaneous | Single-Dose Vial | Rx | November 16, 2017 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 4, 2025 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |