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Inmazeb

atoltivimab, maftivimab, and odesivimab-ebgn

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Inmazeb

Proper name

atoltivimab, maftivimab, and odesivimab-ebgn

Licence type

351(a)

BLA number

761169

Applicant

Regeneron Pharmaceuticals, Inc.

Center

CDER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	October 14, 2020
483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 29, 2021

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 14, 2027

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