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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sulphamic acid, 6,7,8,9,10,11-hexahydro-6-oxobenzo[b]cyclohepta[d]pyran-3-yl ester
Date Designated: 03/16/2026
Orphan Designation: treatment of Huntington's disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Olavide Neuron STX S.L.
Américo Vespucio Street, 5 – 3 D, 1st Floor, Module 12
Seville 41092
Spain

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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