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Crysvita
burosumab-twza
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Crysvita
Proper name
burosumab-twza
Licence type
351(a)
BLA number
761068
Applicant
Kyowa Kirin, Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | April 17, 2018 |
| 20MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | April 17, 2018 |
| 30MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | April 17, 2018 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | September 27, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |