Food and Drug Administration

Endocrinologic & Metabolic Drugs Advisory Committee

January 13, 2003

Slides

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.

Fabrazyme® (agalsidase beta), Alison Lawton, Regulatory Affairs & Quality Systems (HTM) (PPT)

Fabrazyme® Recombinant Human aGalactosidase, Genzyme, Corp. Introduction, FDA (HTM) (PPT)

Genzyme Marketing Application STN 103979/0 Recombinant Human a-Galactosidase for treatment of Fabry Disease (HTM) (PPT)