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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: betibeglogene autotemcel
Trade Name: Zynteglo
Date Designated: 03/18/2013
Orphan Designation: Treatment of B-thalassemia major and intermedia
Orphan Designation Status: Designated/Approved
bluebird bio, Inc.
455 Grand Union Blvd
Somerville, Massachusetts 02145
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: betibeglogene autotemcel
Trade Name: Zynteglo
Marketing Approval Date: 08/17/2022
Approved Labeled Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions
Exclusivity End Date: 08/17/2029 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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