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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eteplirsen
Trade Name: Exondys 51
Date Designated: 10/23/2007
Orphan Designation: Treatment of Duchenne Muscular Dystrophy.
Orphan Designation Status: Designated/Approved
Sarepta Therapeutics, Inc.
215 First Street
Suite 415
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: eteplirsen
Trade Name: Exondys 51
Marketing Approval Date: 09/19/2016
Approved Labeled Indication: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping
Exclusivity End Date: 09/19/2023 
Exclusivity Protected Indication* :  Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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