Search Orphan Drug Designations and Approvals
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Generic Name: | betibeglogene autotemcel | ||||||||||||||||
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Trade Name: | Zynteglo | ||||||||||||||||
Date Designated: | 03/18/2013 | ||||||||||||||||
Orphan Designation: | Treatment of B-thalassemia major and intermedia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | betibeglogene autotemcel |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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