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)