Benzethonium chloride petition
This article was originally published in The Rose Sheet
Executive Summary
Due to "existence of other priorities," FDA currently "unable to respond" to May 15 citizen petition by chemical supplier Lonza seeking Category I status for benzethonium chloride in topical antimicrobials for consumers and healthcare professionals, agency tells company in Nov. 6 letter. Petition requests agency reopen administrative record to allow consideration of new safety and efficacy studies on the ingredient prior to release of final Healthcare Antiseptic Monograph (1"The Rose Sheet" May 27, 2002, p. 10). Monograph's chances for release in 2003 could be improved if it is designated a priority by Center for Drug Evaluation & Research, OTC Drug Products Division Director Charles Ganley, MD, noted in recent speech to industry 2("The Rose Sheet" Nov. 18, 2002, p. 7)...
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