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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
Qurient Co., Ltd.
C-dong 8th Floor 242, Pangyo-ro, Bundang-gu, Seongnam-si
Gyeonggi-do, Korea 463-400
South Korea

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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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