Product Details for: Luxturna

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intraocular
1.5X10 TO 11 ML
Single-Dose Vial
351(a)
Luxturna
Rx
Proper Name
Voretigene Neparvovec
BLA Number
125610
Applicant
Spark Therapeutics, Inc.
Original Approval Date
December 19, 2017
Date of First Licensure