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Thompson Medical

This article was originally published in The Tan Sheet

Executive Summary

Asks FDA in an April 15 letter to reopen the administrative record for OTC topical analgesics to include an additional double-blind, placebo- controlled clinical trial intended to support the efficacy of trolamine salicylate (Thompson Med's Aspercreme) as a topical analgesic to relieve stiffness and pain associated with arthritis. The firm submitted data in December that showed that Aspercreme provided significant improvement over placebo in arthritis relief ("The Tan Sheet" Jan. 24, p. 16). The tentative final monograph for OTC topical analgesics did not include trolamine as a monograph ingredient
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