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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-[[trans-4-[(trifluoromethoxy)phenyl]cyclohexyl]oxy]-1H-1,2,3-triazole-4-carboxylic acid
Date Designated: 06/08/2022
Orphan Designation: Treatment of primary hyperoxaluria type 1
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 05/31/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BioMarin Pharmaceutical Inc.
105 Digital Drive
Novato, California 94949
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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