Centocor’s Centoxin

Executive Summary

U.S. Army seeking approval from FDA to use the monoclonal antibody product for treatment of septic shock in U.S. troops stationed in the Middle East for "Operation Desert Shield." The military has signed an open-ended contract with Centocor to purchase 200 doses of Centoxin, and possibly additional doses, at $2,500 per dose. The company is providing the Army with the information it needs to obtain a special approval (a "combative IND"?) since the drug's approval for marketing in the U.S. is currently pending.