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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: vestronidase alfa-vjbk
Trade Name: Mepsevii
Date Designated: 02/16/2012
Orphan Designation: Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome)
Orphan Designation Status: Designated/Approved
Ultragenyx Pharmaceutical, Inc.
60 Leveroni Court
Novato, California 94949
United States

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

Marketing approved:

1 Generic Name: vestronidase alfa-vjbk
Trade Name: Mepsevii
Marketing Approval Date: 11/15/2017
Approved Labeled Indication: Indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (PMS VII, Sly syndrome).
Exclusivity End Date: 11/15/2024 
Exclusivity Protected Indication* :  Indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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