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Luxturna
Voretigene Neparvovec
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Luxturna
Proper name
Voretigene Neparvovec
Licence type
351(a)
BLA number
125610
Applicant
Spark Therapeutics, Inc.
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 1.5X10 TO 11 ML | Injection | Intraocular | Single-Dose Vial | Rx | December 19, 2017 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 19, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |