Product Information

• Biothrax - Package Insert (PDF - 165KB)
• Information for Patients BioThrax®

Supporting Documents

• 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
  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.
• April 27, 2005 Approval Letter
  Updated to include an extension of dating to 36 months has been approved.
• January 31, 2002 Approval Letter

Related Information

• FDA Online Label Repository
  Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.

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