vestronidase alfa

FDA Drug Profile — MEPSEVII

Drug Details

Generic Name
vestronidase alfa
Brand Names
MEPSEVII
Application Number
BLA761047
Sponsor
Ultragenyx Pharmaceutical Inc.
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
VESTRONIDASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. MEPSEVII is a recombinant human lysosomal beta glucuronidase indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of Use The effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined. ( 1 )