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OTC TOPICAL ANTIFUNGAL TFM CATEGORY I HAS TWO INGREDIENT CHANGES: POVIDONE-IODINE 10% UPGRADED, NAFTIN SLIPS FROM CATEGORY I TO CATEGORY III

Executive Summary

Povidone-iodine 10% is the only ingredient being shifted into Category I (safe and effective) for the treatment of athlete's foot, jock itch and ringworm in the OTC Topical Antifungal Drug Products Tentative Final Monograph. The TFM was published in the Dec. 12 Federal Register. The upgrade affirms a 1985 FDA recommendation based on the agency's review of clinical data provided by Betadine maker Purdue Frederick ("The Pink Sheet" March 11, 1985, T&G-7). The ingredient had originally been classified as Category III by the OTC review panel. In response to the panel's recommendation, the company provided FDA with a 40-patient, double-blind, placebo-controlled clinical trial, a statistical analysis of that study and an in vitro assay of two povidone-iodine solutions for antifungal activity. The in vitro data compared the fungicidal activity of povidone-iodine 10% with and without 0.05% methyl salicylate. The TFM contains two other category switches. Nystatin slipped from Category I to Category III (insufficient data to classify as safe and effective; more data needed). Phenol/phenolate sodium (at concentrations of </- 1.5%) moved from Category II (not recognized as safe and effective) to Category III. The decision not to include nystatin as a Category I ingredient in the TFM is a switch from the recommendation made earlier in the decade by the Advisory Review Panel on OTC Antimicrobial II Drug Products, which placed the ingredient in the safe and effective category for the treatment of vaginal and superficial skin infections caused by Candida albicans. "Because the agency has decided to defer the external feminine itching issue to another rulemaking and has determined that treatment of superficial skin infections caused by yeast (Candida) is not an appropriate OTC claim, nystatin as a single ingredient is not included" in the TFM, the Federal Register notice states. FDA also proposes that claims for treatment of cutaneous candiasis be shifted to professional labeling. Phenol at concentrations of less than or equal 1.5% was moved to Category III because "data are needed to establish that phenol/phenolate sodium is safe for use," FDA said in the TFM notice. The agency based its decision on the OTC panel recommendations. The panel had been concerned that, because the ingredient is used for up to four weeks of treatment time and is applied to large body areas which are then covered by clothing, the product could possibly cause skin irritation and systemic toxicity. Phenol also was classified as Category III for effectiveness. FDA pointed out that "the in vitro concentrations required for effective antifungal action often exceed 1.5%" of phenol. The TFM categorizes 33 classes of ingredients: five are listed as Category I in addition to povidone-iodine 10%; eight as Category II and 19 as Category III (see box, p. 17). OTC TOPICAL ANTIFUNGAL ACTIVE INGREDIENTS From the OTC Topical Antifungal Drug Products Tentative Final Monograph published Dec. 12. Under the safe and effective heading are clioquinol (lodochlorhydroxyquin); haloprigin; miconazole nitrate (Ortho's Micatin); povidone-iodine; tolnaftate (Plough's Aftate) and undecylenic acid (e.g. Cruex, Desenex) and its calcium, copper and zinc salts. For clioquinol, while the agency will allow it to remain on the OTC market for athlete's foot, jock itch and ringworm, "it must be labeled that it is not for use on children under two years of age and that it is not for use for diaper rash," the notice states. Tolnaftate did not receive agency approval for a labeling claim for the prevention of jock itch "due to insufficient data," the TFM concludes. The product is Category I for the treatment of athlete's foot. Ringworm prevention was considered "impractical." The agency is requesting that written comments, objections or requests for oral hearings be made by March 12, 1990 and that new data be submitted by Dec. 12, 1990 with comments on the new data due by Feb. 12, 1991.

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