Anthrax
FDA Grants Fast Track Designation to Emergent BioSolutions' BioThrax for Post-Exposure Prophylaxis against Anthrax Infection
Published in Medical Letter on the CDC and FDA, March 11th, 2007
Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BioThrax(R) (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.
"We are extremely pleased that the FDA has taken this step as we continue our efforts to expand the label indication...
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