Interferon beta-1a

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

Approval Letter (Text)

Label (PDF)

Medication Guides (PDF), (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)

Last Updated: 8/6/2003

Back to Top     Back to Index

Date created: September 23, 2003

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

FDA/Center for Drug Evaluation and Research