Velmanase alfa-tycv

FDA Drug Profile — Lamzede

Drug Details

Generic Name
Velmanase alfa-tycv
Brand Names
Lamzede
Application Number
BLA761278
Sponsor
Chiesi USA, Inc.
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
VELMANASE ALFA-TYCV

Indications and Usage

1 INDICA TIONS AND USAGE LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. LAMZEDE is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. ( 1 )