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Hympavzi
marstacimab-hncq
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hympavzi
Proper name
marstacimab-hncq
Licence type
351(a)
BLA number
761369
Applicant
Pfizer Inc.
Center
CDER
Presentations
4
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | October 11, 2024 |
| 150MG/ML | Injection | Subcutaneous | Autoinjector | Rx | October 11, 2024 |
| 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | June 5, 2026 |
| 75MG/0.5ML | Injection | Subcutaneous | Autoinjector | Rx | June 5, 2026 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 11, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |