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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Trade Name: HyQvia
Date Designated: 03/31/2016
Orphan Designation: Treatment of chronic inflammatory demyelinating polyneuropathy
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
650 E 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: Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Trade Name: HyQvia
Marketing Approval Date: 01/12/2024
Approved Labeled Indication: treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults
Exclusivity End Date: 01/12/2031 
Exclusivity Protected Indication* :  treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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