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Emergent Expands BioThrax Label

FDA approves the vaccine for post-exposure prophylaxis

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The U.S. Food and Drug Administration (FDA) has approved Emergent BioSolutions’ supplemental biologics license application to expand the label of BioThrax (anthrax vaccine adsorbed) to include post-exposure prophylaxis (PEP) of disease following suspected or confirmed Bacillus anthracis exposure when administered in conjunction with recommended antibacterial drugs. The vaccination schedule for this new indication consists of three doses of BioThrax administered at 0, 2, and 4 weeks post-exposure...

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