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Hemgenix
etranacogene dezaparvovec-drlb
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hemgenix
Proper name
etranacogene dezaparvovec-drlb
Licence type
351(a)
BLA number
125772
Applicant
CSL Behring LLC
Center
CBER
Presentations
1
First licensure
November 22, 2022
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1X10E13GENOME COPIES/ML | Injection | Intravenous | Single-Dose Vial | Rx | November 22, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 22, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |