ublituximab

FDA Drug Profile — BRIUMVI

Drug Details

Generic Name
ublituximab
Brand Names
BRIUMVI
Application Number
BLA761238
Sponsor
SAMSUNG BIOLOGICS Co., Ltd.
NDC Codes
3
Dosage Forms
LIQUID, SOLUTION, INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
UBLITUXIMAB-XIIY, UBLITUXIMAB

Indications and Usage

1 INDICATIONS AND USAGE BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 , 14 ).