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Merix OTC shingle relief petition denied

This article was originally published in The Tan Sheet

Executive Summary

FDA denies Merix Pharmaceutical's requests to amend three OTC monographs by allowing the combination of monograph ingredients in the product Shing-Releev for treatment of shingles and chicken pox,and in Releev for treatment of fever blisters and cold sores. The Barrington, Ill., company petitioned FDA in October 2008 to permit the combination of the skin protectant allantoin, the first-aid antiseptic bezalkonium chloride and the external analgesic benzyl alcohol for symptomatic relief of shingles and chicken pox, and separately petitioned for a fever blister/cold sore relief indication for the ingredients (1"The Tan Sheet" Jan. 5, 2009). In a May 3 2letter, FDA says shingles is not an OTC indication and it requires clinical studies showing the ingredients' efficacy on chicken pox symptoms. The agency notes in a separate 3letter that, while fever blister and cold sore relief is a monographed indication, a product combining active ingredients from three separate monographs requires a new drug application
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