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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride
Date Designated: 09/04/2014
Orphan Designation: Treatment of Huntington's disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/06/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Prana Biotechnology Limited
Level 2, 369 Royal Parade
Parkville, Victoria
Australia

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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