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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
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 Jan. 1, 2013, to the present.