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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Vaccinia Immune Globulin (Human) Intravenous
Trade Name:
Date Designated: 06/18/2004
Orphan Designation: Treatment of severe complications from the smallpox vaccine
Orphan Designation Status: Designated/Approved
DynPort Vaccine Company LLC
64 Thomas Johnson Drive
Frederick, Maryland 21702
United States

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

Marketing approved:

1 Generic Name: Vaccinia Immune Globulin (Human) Intravenous
Trade Name:
Marketing Approval Date: 02/18/2005
Approved Labeled Indication: Treatment and modification of aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard; eczema vaccinatum; progressive vaccinia; severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
Exclusivity End Date: 02/18/2012 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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