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Zolgensma
onasemnogene abeparvovec-xioi
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Zolgensma
Proper name
onasemnogene abeparvovec-xioi
Licence type
351(a)
BLA number
125694
Applicant
Novartis Gene Therapies, Inc.
Center
CBER
Presentations
1
First licensure
May 24, 2019
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 2x10^13VG/ML | Injection | Intravenous | Single-Dose Vial | Rx | May 24, 2019 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 24, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |