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Evkeeza

evinacumab-dgnb

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Evkeeza

Proper name

evinacumab-dgnb

Licence type

351(a)

BLA number

761181

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
1,200MG/8ML (150MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	February 11, 2021
345MG/2.3ML (150MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	February 11, 2021

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 21, 2030

Sources for this page

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