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Trolamine salicylate

This article was originally published in The Tan Sheet

Executive Summary

Feedback meeting between FDA and Chattem will be held May 1 to discuss ingredient's status in external analgesic tentative final monograph; trolamine salicylate is active in Chattem's Aspercreme and Sportscreme. FDA recently denied a petition seeking Category I status for the ingredient due to "inadequate" data (1"The Tan Sheet" Jan. 8, In Brief)

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OTC external analgesics

FDA denies petition seeking Category I status for trolamine salicylate, the active ingredient in Chattem's Aspercreme and Sportscreme, because "the data submitted...were inadequate to support the petition request." Thompson Medical submitted the original citizen petition in 1981 and sent the agency three additional trials in the mid-1990s demonstrating the ingredient's effectiveness as a topical analgesic for relief of pain and stiffness associated with arthritis. Chattem acquired Thompson and its product line in November 1998. FDA originally issued the denial letter Aug. 18 to Thompson but later forwarded the correspondence to Chattem after learning of the acquisition. Although the ingredient remains Category III, Chattem says it may submit additional clinical data

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