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CPC petition

This article was originally published in The Rose Sheet

Executive Summary

Objections by Schering-Plough to include .05% cetylpyridium chloride nasal spray as Category I for safety and efficacy in the Oral Antiseptic Drug Products Tentative Final Monograph support the reopening of the administrative record, SinoFresh asserts in Oct. 12 comments to FDA, citing Schering's conclusions that CPC is safe for use in the oral cavity and effective in suppressing superinfective organisms. Schering submitted comments to FDA in July arguing the nasal spray should not be included in the TFM. SinoFresh also cited approval of CPC in April as an antimicrobial agent in poultry processing, and FDA's request for comments on topically applied nasal decongestants carrying sinusitis claims and nasal moisturizers as a reason to reopen the docket. The firm submitted a citizen petition to the agency seeking inclusion of the nasal spray in the TFM in 2003 (1"The Rose Sheet" April 7, 2003, p. 10)...

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