ibalizumab

FDA Drug Profile — TROGARZO

Drug Details

Generic Name
ibalizumab
Brand Names
TROGARZO
Application Number
BLA761065
Sponsor
Samsung BioLogics Co. LTD
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION, LIQUID, INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
IBALIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen. TROGARZO, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.