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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant human highly phosphorylated alpha-L-iduronidase (rhHP-IDUA)
Date Designated: 04/11/2001
Orphan Designation: Enzyme replacement therapy in patients with all subtypes of Mucopolysaccharidosis I.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novazyme Pharmaceuticals, Inc.
800 Research Parkway
Suite 200
Oklahoma City, Oklahoma 73104
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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