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Emergent BioSolutions Inc receives Orphan Drug designation for BioThrax for Post-Exposure Prophylaxis of Anthrax Disease

Monday, 21 Apr 2014 07:00am EDT 

Emergent BioSolutions Inc:U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.Orphan status is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in U.S.This designation provides incentives to BioThrax PEP Program, including waiver of Biologics License Application (BLA) supplemental regulatory filing fee and marketing exclusivity of up to seven years. 

Company Quote

0.68 +1.93%
12 Feb 2016