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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Anthrax Vaccine Adsorbed
Trade Name: BioThrax
Date Designated: 04/11/2014
Orphan Designation: For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure
Orphan Designation Status: Designated/Approved
Emergent BioDefense Operations Lansing LLC
300 Proessional Drive
Gaithersburg, Maryland 20879
United States

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

Marketing approved:

1 Generic Name: Anthrax Vaccine Adsorbed
Trade Name: BioThrax
Marketing Approval Date: 11/23/2015
Approved Labeled Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.
Exclusivity End Date: 11/23/2022 
Exclusivity Protected Indication* :  For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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