Interferon beta-1a
Product Approval Information - Licensing Action
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
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Date created: September 23, 2003 |