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)
You may also be interested in...
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
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands