Colgate supports "antiplaque" statement of identity for monograph products.
This article was originally published in The Tan Sheet
Executive Summary
ANTIGINGIVITIS AGENTS "ANTIMICROBIAL" STATEMENT OF IDENTITY is "not consistent" with the deliberations of FDA's Dental Plaque Subcommittee, Sheila McGuire-Riggs, DDS, Wellmark, Blue Cross/Blue Shield of Iowa, a subcommittee member, declared at a May 28 meeting in Gaithersburg, Md. The advisory group met to discuss labeling for FDA's OTC antigingivitis drug products monograph, as well as final formulation testing requirements for products included in the rulemaking.