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HERBERT LABS' NAFTIN TOPICAL ANTI-FUNGAL CREAM SCHEDULED FOR JUNE LAUNCH

Executive Summary

Herbert Labs is planning a June market introduction for its recently approved topical anti-fungal Naftin (naftifine), the SmithKline/Allergan subsidiary told "The Pink Sheet." The cream product cleared FDA on Feb. 29 as a 1C drug (new molecular entity with little or no therapeutic gain). Herbert filed its NDA in March 1986. Despite indications from FDA that the approval momentum from the end of 1987 would continue into the first quarter of 1988, Naftin was apparently the only new chemical entity approved during the past three months. FDA also recently approved McNeil's anti-motility agent loperamide for use as an OTC product ("The Pink Sheet" March 14, p. 15). "Naftin Cream is indicated for the topical treatment of tinea cruris and tinea corporis," the product labeling states. Naftin will be supplied in 2, 15 and 30 gram tubes. The product will be priced to wholesalers at $ 6.48 per 15 g tube and $ 11.05 per 30 g tube. SmithKline said.
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