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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 (human)
Trade Name: Gammagard Liquid
Date Designated: 07/20/2006
Orphan Designation: Treatment of multifocal motor neuropathy
Orphan Designation Status: Designated/Approved
Baxalta US, Inc.
One Baxter Way
Westlake Village, California 91362
United States

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

Marketing approved:

1 Generic Name: immune globulin infusion (human)
Trade Name: Gammagard Liquid
Marketing Approval Date: 06/22/2012
Approved Labeled Indication: Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
Exclusivity End Date: 06/22/2019 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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