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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: human monoclonal anti-PA antibody
Date Designated: 10/21/2010
Orphan Designation: For post-exposure prophylaxis and treatment of inhalation anthrax.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/19/2016
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Emergent Product Development Gaithersburg, Inc.
300 Professional Drive
Gaithersburg, Maryland 20879
United States

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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