STN: BL 103821
Proper Name: Anthrax Vaccine Adsorbed
Manufacturer: Emergent BioDefense Operations Lansing LLC
- For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.
November 23, 2015 Approval Letter - Biothrax(PDF - 42KB)
To include post-exposure prophylaxis (PEP) of disease resulting from suspected or confirmed Bacillus anthracis exposure, when combined with the recommended course of antimicrobial therapy in persons 18 through 65 years of age.
November 11, 2015 Summary Basis for Regulatory Action - BioThrax(PDF - 159KB) May 17, 2012 Summary Basis for Regulatory Action - BioThrax(PDF - 152KB) May 17, 2012 Approval Letter - BioThrax
To change the dosing schedule from a five-dose primary schedule at 0, 1, 6, 12, 18 months with annual booster to a three-dose primary schedule at 0, 1, 6 months.
September 16, 2010 Approval Letter - BioThrax[ARCHIVED]
Patient Package Insert (PPI).
December 11, 2008 Approval Letter
Updated to to include a change in schedule from 0, 2, 4 weeks and 6, 12 and 18 months to 0, 4 weeks, and 6, 12, and 18 months, and a change in route of administration from subcutaneous to intramuscular.
January 31, 2002 Approval Letter April 27, 2005 Approval Letter[ARCHIVED]
Updated to include an extension of dating to 36 months has been approved.
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