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Cosentyx

secukinumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Cosentyx

Proper name

secukinumab

Licence type

351(a)

BLA number

761349

Applicant

Novartis Pharmaceuticals Corporation

Center

CDER

Presentations

7

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
125MG/5ML	Injection	Intravenous	Single-Dose Vial	Rx	October 6, 2023
150MG	For Injection	Subcutaneous	Single-Dose Vial	Disc	January 21, 2015
150MG/ML	Injection	Subcutaneous	Autoinjector	Rx	January 21, 2015
150MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	January 21, 2015
300MG/2ML	Injection	Subcutaneous	Autoinjector	Rx	May 11, 2023
300MG/2ML	Injection	Subcutaneous	Pre-Filled Syringe	Disc	May 11, 2023
75MG/0.5ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	May 28, 2021

Sources for this page

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