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Kineret

anakinra

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Kineret

Proper name

anakinra

Licence type

351(a)

BLA number

103950

Applicant

Swedish Orphan Biovitrum AB (publ)

Center

CDER

Presentations

1

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
100MG/0.67ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	November 14, 2001

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	December 18, 2027

Sources for this page

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