AGALSIDASE BETA

FDA Drug Profile — Fabrazyme

Drug Details

Generic Name
AGALSIDASE BETA
Brand Names
Fabrazyme
Application Number
BLA103979
Sponsor
Genzyme Corporation
NDC Codes
3
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
AGALSIDASE BETA

Indications and Usage

1 INDICATIONS AND USAGE FABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. FABRAZYME is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. ( 1 )