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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (2R,3R,4S)-2-(2-chloro-6-(3-chlorobenzylamino)-9H-purin-9-yl)tetrahydrothiophene-3,4-diol
Date Designated: 02/01/2021
Orphan Designation: Treatment of Primary Biliary Cholangitis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Future Medicine Co., Ltd.
Rm616, LH Business Growth Center, 54 Changeop-ro, Sujeong-gu
Seongnam, Gyeonggi-do
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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