Food and Drug Administration

Endocrinologic and Metabolic  Drugs Advisory Committee

January 14, 2003

Briefing Information

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.

Preliminary Discussion Topics Agalsidase alfa for the Treatment of Fabry Disease Transkaryotic Therapies, Inc. (Word) (PDF) (HTM)

Endocrinologic and Metabolic Drugs Advisory Committee Briefing Document, Prepared by: Transkaryotic Therapies, Inc., Submitted: December 12, 2002  (PDF)

FDA Briefing Document BLA STN 103977/0, Transkaryotic Therapies, Inc., Agalsidase Alfa Alpha-Galactosidase A, For Treatment of Fabry Disease, December 12, 2002 (Word) (PDF)