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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: obiltoxaximab
Trade Name: Anthim
Date Designated: 06/09/2006
Orphan Designation: Treatment of exposure to B. anthracis spores
Orphan Designation Status: Designated/Approved
Elusys Therapeutics, Inc.
25 Riverside Drive
P.O. Box 102
Pine Brook, New Jersey 07058
United States

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

Marketing approved:

1 Generic Name: obiltoxaximab
Trade Name: Anthim
Marketing Approval Date: 03/18/2016
Approved Labeled Indication: Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate.
Exclusivity End Date: 03/18/2023 
Exclusivity Protected Indication* :  1) Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and (2) for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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