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Roctavian

valoctocogene roxaparvovec-rvox

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Roctavian

Proper name

valoctocogene roxaparvovec-rvox

Licence type

351(a)

BLA number

125720

Applicant

Biomarin Pharmaceutical Inc.

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
16X 10E13GENOMES PER ML	Injection	Intravenous	Single-Dose Vial	Disc	June 29, 2023

Source: Purple Book

Kind	Expires
Orphan exclusivity	June 29, 2030

Purple Book	FDA	Licence type, presentations, reference product, exclusivity