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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ganaxolone
Date Designated: 12/28/2016
Orphan Designation: Treatment of Fragile X Syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marinus Pharmaceuticals
170 North Radnor Chester Road
Suite 250
Radnor, Pennsylvania 19087
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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