Therapeutic Antibodies CroTAb
Executive Summary
PLA submitted April 24, and received by FDA April 27 for antivenom product to neutralize poisonous effects of bites from North American crotalids or pit vipers. The Nashville-based firm has requested a priority review. The polyclonal antibody has been granted orphan status; an estimated 8,000 people annually are treated for the snake bites. Altana will market CroTAb under an October 1998 agreement...