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betibeglogene autotemcel

FDA Drug Profile — Zynteglo

Drug Details

Generic Name
betibeglogene autotemcel
Brand Names
Zynteglo
Application Number
BLA125717
Sponsor
Genetix Biotherapeutics Inc.
NDC Codes
1
Dosage Forms
SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
BETIBEGLOGENE AUTOTEMCEL

Indications and Usage

1 INDICATIONS AND USAGE ZYNTEGLO is indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. ZYNTEGLO is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of adult and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions. ( 1 )