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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Telacebec
Date Designated: 01/13/2021
Orphan Designation: Treatment of Buruli ulcer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
The Global Alliance for TB Drug Development, Inc.
80 Pine Street, 20th Floor
New York, New York 10005
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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