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Private label miconazole combo packs

This article was originally published in The Tan Sheet

Executive Summary

Alpharma receives approval April 16 for ANDA 74-926 and Perrigo, April 20 for ANDA 75-926, allowing both to market three-day miconazole vaginal antifungal treatment combination packs. Equivalent to the reference drug J&J's Monistat 3 Combination Pack, each contains three 200 mg miconazole nitrate suppositories and a 9 g tube of 2% miconazole nitrate cream. Waxman/Hatch marketing exclusivity for Monistat 3 ended April 16, opening up competition for the brand's 5.6% dollar share, reported by Chicago-based Information Resources, Inc. to be worth nearly $68 mil. at U.S. food, drug and mass merchandisers for the 52 weeks ended March 28

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