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Kevzara

sarilumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kevzara

Proper name

sarilumab

Licence type

351(a)

BLA number

761037

Applicant

Sanofi-Aventis U.S. LLC

Center

CDER

Presentations

4

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
150MG/1.14ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	May 22, 2017
150MG/1.14ML	Injection	Subcutaneous	Autoinjector	Rx	April 13, 2018
200MG/1.14ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	May 22, 2017
200MG/1.14ML	Injection	Subcutaneous	Autoinjector	Rx	April 13, 2018

Sources for this page

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