Food and Drug Administration

Endocrinologic and Metabolic  Drugs Advisory Committee

January 13, 2003

Briefing Information

Fabrazyme (agalsidase beta)

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Agenda Draft (Word) (PDF) (HTM)

Fabrazyme (agalsidase beta) Briefing Document (PDF)

Supplementary Background Information on Accelerated Approval Regulations and Orphan Drug Regulations (Word) (PDF) (HTM)

Advisory Committee Briefing Document, Genzyme Corp., Biologics Marketing Application STN 103979/0, Recombinant Human a-Galactosidase for Fabry's Disease, December 12, 2002 (Word) (PDF) (HTM)

Genzyme Historical Dataset for Use as Study Control Group, December 12, 2002 (Word) (PDF) (HTM)