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Blenrep

belantamab mafodotin-blmf

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Blenrep

Proper name

belantamab mafodotin-blmf

Licence type

351(a)

BLA number

761158

Applicant

GlaxoSmithKline Intellectual Property Development Ltd. England

Center

CDER

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
100MG	For Injection	Intravenous	Single-Dose Vial	Disc	August 5, 2020
70MG	For Injection	Intravenous	Single-Dose Vial	Rx	October 23, 2025

Source: Purple Book

Kind	Expires
Orphan exclusivity	August 5, 2027

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