Search Orphan Drug Designations and Approvals
-
| 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 | |||||||||||||
| Sponsor: |
bluebird bio, Inc. 60 Binney Street Cambridge, Massachusetts 02142 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: | TBD | |
-
