FDA Grants Fast Track Designation To Emergent BioSolutions’ BioThrax(R) For Post-Exposure Prophylaxis Against Anthrax Infection

ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BioThrax® (Anthrax Vaccine Adsorbed) as a post-exposure prophylaxis against anthrax infection. BioThrax is the only FDA approved product for pre-exposure prophylaxis of anthrax infection. The company plans to seek FDA approval of BioThrax for use in combination with antibiotics as a post-exposure prophylaxis for anthrax infection. The company is targeting a three dose regimen given two weeks apart for this indication.
MORE ON THIS TOPIC