Xttrium Labs' Exidine
Executive Summary
Firm is petitioning FDA for three years marketing exclusivity for its Exidine antimicrobial cleansing agent (chlorhexidine gluconate 2% and 2.5% solution). Xttrium says its products, approved in December, are entitled to exclusivity because FDA required clinical investigations for approval. Xttrium noted that the studies, glove juice and health care personnel hand washing, "had never been previously used in the drug approval process" for chlorhexidine products.