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Lynozyfic

linvoseltamab-gcpt

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Lynozyfic

Proper name

linvoseltamab-gcpt

Licence type

351(a)

BLA number

761400

Applicant

Regeneron Pharmaceuticals, Inc.

Center

CDER

Presentations

2

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
200MG/10ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	July 2, 2025
5MG/2.5ML (2MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	July 2, 2025

Sources for this page

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