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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: viltolarsen
Trade Name: VILTEPSO
Date Designated: 01/12/2017
Orphan Designation: Treatment of Duchenne Muscular Dystrophy
Orphan Designation Status: Designated/Approved
NS Pharma, Inc.
140 East Ridgewood Avenue, Suite 280S
Paramus, New Jersey 07652
United States

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

Marketing approved:

1 Generic Name: viltolarsen
Trade Name: VILTEPSO
Marketing Approval Date: 08/12/2020
Approved Labeled Indication: VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping
Exclusivity End Date: 08/12/2027 
Exclusivity Protected Indication* :  VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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