ibalizumab

FDA Drug Profile — TROGARZO

ibalizumab is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including TROGARZO. Available dosage forms: liquid, injection, solution, solution.

Drug Details

Generic Name
ibalizumab
Brand Names
TROGARZO
Application Number
BLA761065
Sponsor
SAMSUNG BIOLOGICS Co., Ltd.
NDC Codes
3
Dosage Forms
LIQUID, INJECTION, SOLUTION, 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.