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Actemra

tocilizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Actemra

Proper name

tocilizumab

Licence type

351(a)

BLA number

125472

Applicant

Genentech, Inc.

Center

CDER

Presentations

5

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
162MG/0.9ML	Injection	Subcutaneous	Pre-Filled Syringe	Rx	October 21, 2013
162MG/0.9ML	Injection	Subcutaneous	Autoinjector	Rx	November 19, 2018
200MG/10ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 8, 2010
400MG/20ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 8, 2010
80MG/4ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 8, 2010

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	September 4, 2028

Sources for this page

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