BioThrax receives FDA approval
The FDA has approved Emergent BioSolutions Inc.'s supplemental Biologics License Application (sBLA) for BioThrax (Anthrax Vaccine Adsorbed). This supplement provides for a change in the route of administration and a reduction in the total number of vaccinations. The new schedule is 5 doses given intramuscularly (IM) at 0, 1, 6, 12 and 18 months compared to the former schedule of 6 doses given subcutaneously (SC) at 0, 2 weeks and 1, 6, 12, 18 months.
BioThrax is indicated for the prevention of anthrax infection in persons 18-65 years of age at high risk exposure.
BioThrax is available as a suspension for injection in 5.0mL multidose vials containing 10 doses each.
For more information call (877) BIOTHRAX or visit www.emergentbiosolutions.com.