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Adlyxin

lixisenatide

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Adlyxin

Proper name

lixisenatide

Licence type

351(a)

BLA number

208471

Applicant

Sanofi-Aventis U.S. LLC

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
150MCG/3ML (50MCG/ML)	Injection	Subcutaneous	Autoinjector	Disc	July 27, 2016
300MCG/3ML (100MCG/ML)	Injection	Subcutaneous	Autoinjector	Disc	July 27, 2016

Sources for this page

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