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Beqvez
fidanacogene elaparvovec-dzkt
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Beqvez
Proper name
fidanacogene elaparvovec-dzkt
Licence type
351(a)
BLA number
125786
Applicant
Pfizer Inc.
Center
CBER
Presentations
1
First licensure
April 25, 2024
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1x E13 VG/ML | Suspension | Intravenous | Single-Dose Vial | Disc | April 25, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 25, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |