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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: elosulfase alfa
Trade Name: Vimizim
Date Designated: 05/15/2009
Orphan Designation: Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome)
Orphan Designation Status: Designated/Approved
BioMarin Pharmaceutical Inc.
105 Digital Drive
Novato, California 94949
United States

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

Marketing approved:

1 Generic Name: elosulfase alfa
Trade Name: Vimizim
Marketing Approval Date: 02/14/2014
Approved Labeled Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)
Exclusivity End Date: 02/14/2021 
Exclusivity Protected Indication* :  Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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