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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: amifampridine phosphate
Date Designated: 03/03/2015
Orphan Designation: Treatment of congenital myasthenic syndromes
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 03/14/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Catalyst Pharmaceuticals
(dba Catalyst Pharmaceutical Partner, Inc)
Suite 1500
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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