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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 3,4-diaminopyridine
Date Designated: 03/30/2017
Orphan Designation: Treatment of congenital myasthenic syndrome (CMS)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Catalyst Pharmaceuticals, Inc.
355 Alhambra Circle
Suite 801
Coral Gables, Florida 33134
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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