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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: competitive and reversible small molecule inhibitor of the O-linked-B-N-acetylglucosaminidase enzyme
Date Designated: 07/10/2018
Orphan Designation: Treatment of progressive supranuclear palsy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
Barcelona E-08028
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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