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tecelra

afamitresgene autoleucel

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

tecelra

Proper name

afamitresgene autoleucel

Licence type

351(a)

BLA number

125789

Applicant

USWM CT, LLC

Center

CBER

Presentations

First licensure

August 1, 2024

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1.62 x 10^9 to 10 x 10^9 CELL/ML	Suspension	Intravenous	Bag	Rx	June 17, 2026
2.68 x 10^9 to 10 x 10^9 CELL/ML	Suspension	Intravenous	Bag	Rx	August 1, 2024

Source: Purple Book

Kind	Expires
Orphan exclusivity	August 1, 1931

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