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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: dalfampridine
Trade Name: Ampyra
Date Designated: 06/02/1987
Orphan Designation: Relief of symptoms of multiple sclerosis
Orphan Designation Status: Designated/Approved
Acorda Therapeutics
15 Skyline Dr.
Hawthorne, New York 10532
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: dalfampridine
Trade Name: Ampyra
Marketing Approval Date: 01/22/2010
Approved Labeled Indication: Treatment to improve walking in patients with multiple sclerosis
Exclusivity End Date: 01/22/2017 
Exclusivity Protected Indication* :  

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.