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Breyanzi

lisocabtagene maraleucel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Breyanzi

Proper name

lisocabtagene maraleucel

Licence type

351(a)

BLA number

125714

Applicant

Juno Therapeutics, Inc. a Bristol Myer-Squibb Company

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
4.6ML/VIAL	Injection	Intravenous	Single-Dose Vial	Rx	February 5, 2021

Source: Purple Book

Kind	Expires
Orphan exclusivity	May 30, 1931

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