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Yescarta

axicabtagene ciloleucel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Yescarta

Proper name

axicabtagene ciloleucel

Licence type

351(a)

BLA number

125643

Applicant

Kite Pharma, Inc.

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
2 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT	Injection	Intravenous	Bag	Rx	October 18, 2017

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 5, 1933

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