Garadacimab

FDA Drug Profile — ANDEMBRY

Drug Details

Generic Name
Garadacimab
Brand Names
ANDEMBRY
Application Number
BLA761367
Sponsor
CSL
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
GARADACIMAB

Indications and Usage

1 INDICATIONS AND USAGE ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )