|
Agalsidase beta
Product Approval Information - Licensing Action
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
Approval Letter
(Text)
Label
(PDF)
Reviews:
Statistical - 4/24/2003
(PDF)
Clinical - 4/23/2003
(PDF)
CMC - 8/4/2000
(PDF)
CMC - 12/12/2000
(PDF),
(Text)
Clinical - 4/21/2003
(PDF)
Clinical - 4/22/2003
(PDF)
Talkpaper
Last Updated: 6/16/2003
 Back
to Top 
Back to Index
Date created: September 16, 2003 |
