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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: doxecitine and doxribtimine
Trade Name: Kygevvi
Date Designated: 07/07/2016
Orphan Designation: Treatment of thymidine kinase 2 deficiency.
Orphan Designation Status: Designated/Approved
UCB, Inc.
1950 Lake Park Drive, Bldg 2100
Smyrna, Georgia 30080
United States

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

Marketing approved:

1 Generic Name: doxecitine and doxribtimine
Trade Name: Kygevvi
Marketing Approval Date: 11/03/2025
Approved Labeled Indication: treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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