On December 14, 2012, the FDA approved Raxibacumab, the first monoclonal 
antibody product developed under Project BioShield to achieve this milestone, 
and the first biologic product to be approved through the FDA animal efficacy 
rule (or "Animal Rule"). Raxibacumab is approved for the treatment of adult and 
pediatric patients with inhalational anthrax due to Bacillus anthracis in 
combination with appropriate antibiotic drugs and for prophylaxis of 
inhalational anthrax when alternative therapies are not available or not 
appropriate. The developmental process required for approval of Raxibacumab 
illustrates many of the challenges that product developers may encounter when 
pursuing approval under the Animal Rule and highlights a number of important 
regulatory and policy issues.