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Ilaris

canakinumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ilaris

Proper name

canakinumab

Licence type

351(a)

BLA number

125319

Applicant

Novartis Pharmaceuticals Corporation

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
150MG	For Injection	Subcutaneous	Single-Dose Vial	Disc	June 17, 2009
150MG/ML	Injection	Subcutaneous	Single-Dose Vial	Rx	December 22, 2016

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	June 16, 2027

Sources for this page

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