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Brineura

cerliponase alfa

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Brineura

Proper name

cerliponase alfa

Licence type

351(a)

BLA number

761052

Applicant

BioMarin Pharmaceutical Inc.

Center

CDER

Presentations

1

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
150MG/5ML (30MG/ML)	Injection	Intraventricular	Single-Dose Vial	Rx	April 27, 2017

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	July 24, 1931

Sources for this page

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