Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.


Interferon beta-1a Product Approval Information - Licensing Action 5/28/03

Proper name: Interferon beta-1a
Tradename: AVONEX
Manufacturer: Biogen, Inc, Cambridge, MA, License #1204
Indication for Use: To include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form
Approval Date: 5/28/2003
Type of submission: Biologics license application supplement


Label (PDF)

Medication Guides (PDF)

CMC Review - 8-14-02 (PDF)

Clinical Review (PDF)

Assay Validation Review (PDF)

Toxicologist Review (PDF)

Immunogenicity Review - 9-4-02 (PDF)

Immunogenicity Review - 4-29-03 (PDF)

CMC Review - 7-19-02 (PDF)

Pharm / Tox Review (PDF)

Page Last Updated: 09/30/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English