Xttrium's chlorhexidine gluconate
Executive Summary
Firm has filed two petitions with FDA requesting marketing exclusivity for an aerosol product and a solution product, each containing 4% chlorhexidine gluconate, and for two solution products containing 2% and 2.5% concentrations of the antimicrobial agent. Xttrium maintained that glove juice studies and hand washing studies it was required to conduct constituted new clinical investigations that meet criteria for three year exclusivity.