STN: 125717
Proper Name: betibeglogene autotemcel
Tradename: ZYNTEGLO
Manufacturer: bluebird bio Inc.
Indication:

• For treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell (RBC) transfusions

Product Information

• Package Insert - ZYNTEGLO

Supporting Documents

• August 17, 2022 Approval Letter - ZYNTEGLO

Related Information

• FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions