Agalsidase beta Product Approval Information - Licensing Action 4/24/03

Proper name: Agalsidase beta
Tradename: Fabrazyme
Manufacturer: Genzyme Corp, Cambridge, MA , License #1596
Indication for Use: For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
Approval Date: 4/24/2003
Type of submission: Biologics license application

Label (PDF)

Reviews:

Statistical - 4/24/2003 (PDF)

Clinical - 4/23/2003 (PDF)

CMC - 8/4/2000 (PDF)

CMC - 12/12/2000 (PDF)

Clinical - 4/21/2003 (PDF)

Clinical - 4/22/2003 (PDF)