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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 Intravenous (Human)
Trade Name: Octagam 10%
Date Designated: 04/19/2017
Orphan Designation: Treatment of dermatomyositis
Orphan Designation Status: Designated/Approved
OCTAPHARMA USA, Inc.
117 West Century Road
Paramus, New Jersey 07652
United States

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

Marketing approved:

1 Generic Name: Immune Globulin Intravenous (Human)
Trade Name: Octagam 10%
Marketing Approval Date: 07/15/2021
Approved Labeled Indication: Treatment of dermatomyositis in adults
Exclusivity End Date: 07/15/2028 
Exclusivity Protected Indication* :  Treatment of dermatomyositis 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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