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Xenpozyme
olipudase alfa-rpcp
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Xenpozyme
Proper name
olipudase alfa-rpcp
Licence type
351(a)
BLA number
761261
Applicant
Genzyme Corporation
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 20MG | For Injection | Intravenous | Single-Dose Vial | Rx | August 31, 2022 |
| 4MG | For Injection | Intravenous | Single-Dose Vial | Rx | March 31, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 31, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |