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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (S)-4-((1-Benzylpyrrolidin-3-yl)(methyl)amino)-2-fluoro-5-methyl-N-(thiazol-4-yl)benzenesulfonamide
Date Designated: 09/10/2020
Orphan Designation: Treatment of sodium channel, voltage-gated, type VIII, alpha subunit (SCN8A) developmental and epileptic encephalopathy syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neurocrine Biosciences Inc.
12780 El Camino Real
San Diego, California 92130
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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