Food and Drug Administration

Endocrinologic & Metabolic Drugs Advisory Committee

January 13, 2003


Fabrazyme® (agalsidase beta)


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)