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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
Trade Name: Ztalmy
Date Designated: 06/28/2017
Orphan Designation: Treatment of cyclin-dependent kinase-like 5 (CDKL5) gene-related early-onset infantile epileptic encephalopathy
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: ganaxolone
Trade Name: Ztalmy
Marketing Approval Date: 06/01/2022
Approved Labeled Indication: Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older
Exclusivity End Date: 06/01/2029 
Exclusivity Protected Indication* :  Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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