olipudase alfa-rpcp

FDA Drug Profile — XENPOZYME

Drug Details

Generic Name
olipudase alfa-rpcp
Brand Names
XENPOZYME
Application Number
BLA761261
Sponsor
Genzyme Corporation
NDC Codes
2
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
OLIPUDASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. ( 1 )