galsulfase

FDA Drug Profile — NAGLAZYME

Drug Details

Generic Name
galsulfase
Brand Names
NAGLAZYME
Application Number
BLA125117
Sponsor
BioMarin Pharmaceutical Inc.
NDC Codes
2
Dosage Forms
SOLUTION
Routes
INTRAVENOUS
Active Ingredients
GALSULFASE

Indications and Usage

1 INDICATIONS AND USAGE NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. NAGLAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. ( 1 )