Interferon beta-1a Product Approval Information - Licensing Action

Proper name: Interferon beta-1a
Tradename: Rebif
Manufacturer: Serono, Inc, Rockland, MA, License #1574
Indication for Use: Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability
Approval Date: 3/7/2002
Type of submission: Biologics license application

Approval Letter (PDF)

Comparative Study - (PDF)

Office of Orphan Products Development Analysis - (PDF)

Medical Officer's Review - (PDF)

Medical Officer's Clinical Review - (PDF)

Consult Review - (PDF)

Stability Review - (PDF)

Stability Review (addendum) - (PDF)

CMC Review 1 - (PDF)

CMC Review 2 - (PDF)

CMC Review 3 - (PDF)

Statistical Review - (PDF)

Statistical Review 2 - (PDF)

Toxicology Review - (PDF)

Immunogenicity Review - (PDF)

Label - (PDF)

Medication Guide - (PDF)