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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: idursulfase
Trade Name: Elaprase
Date Designated: 11/28/2001
Orphan Designation: Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome)
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: idursulfase
Trade Name: Elaprase
Marketing Approval Date: 07/24/2006
Approved Labeled Indication: Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Idursulfase has been shown to improve walking capacity in these patients
Exclusivity End Date: 07/24/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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