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Benzethonium Chloride Finished Product Studies Support Efficacy – Lonza

This article was originally published in The Rose Sheet

Executive Summary

Safety and efficacy studies on the use of benzethonium chloride in finished product formulas support a Category I classification of the ingredient in the healthcare antiseptic monograph, chemical supplier Lonza says in a May 15 citizen petition to FDA

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Benzethonium chloride petition

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)...

Benzethonium chloride petition

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)...

FDA review of benzethonium chloride

Evaluation of data submitted by Lonza to support its request that benzethonium chloride be classified a Category I active ingredient in the healthcare antiseptics monograph will be included in final rule, FDA tells the firm in a Nov. 5 letter. "The agency intends to fully consider all relevant data on benzethonium chloride available to us before making a decision on the ingredient's status in the final rule," letter says. However, FDA adds, because the agency is developing the rule, it is required to limit communication with interested parties and is unable to meet with Lonza on the subject. Chemical ingredient supplier requested FDA complete a safety review of benzethonium chloride prior to finalizing the rule in a Sept. 17 letter (1"The Rose Sheet" Oct. 29, p. 8)...

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