teplizumab-mzwv

FDA Drug Profile — TZIELD

Drug Details

Generic Name
teplizumab-mzwv
Brand Names
TZIELD
Application Number
BLA761183
Sponsor
Provention Bio, Inc.
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
TEPLIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes [see Dosage and Administration ( 2.1 )] . TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D ( 1 ).