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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sulthiame
Date Designated: 07/25/2013
Orphan Designation: Treatment of patients with benign epilepsy of childhood with centrotemporal spikes (BECTS) also known as rolandic epilepsy
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marathon Pharmaceuticals, LLC
1033 Skokie Blvd.,
Suite 600
Northbrook, Illinois 60062
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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