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Tecartus

Brexucabtagene Autoleucel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Tecartus

Proper name

Brexucabtagene Autoleucel

Licence type

351(a)

BLA number

125703

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
210^6 CAR-positive viable T cells per kg body weight	For Injection	Intravenous	Bag	Rx	July 24, 2020

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 1, 2028

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