Vaccines, Blood & Biologics
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Biothrax
STN: BL 103821
Proper Name: Anthrax Vaccine Adsorbed
Tradename: Biothrax
Manufacturer: Emergent BioDefense Operations Lansing Inc., License #1755
Indication:
- 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.
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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
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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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