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Zynteglo
betibeglogene autotemcel
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zynteglo
Proper name
betibeglogene autotemcel
Licence type
351(a)
BLA number
125717
Applicant
Genetix Biotherapeutics Inc.
Center
CBER
Presentations
1
First licensure
August 17, 2022
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.7-20 X 10^6CELL/ML | For Injection | Intravenous | Bag | Rx | August 17, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 17, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |