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FDA approves Perrigo's miconazole

This article was originally published in The Tan Sheet

Executive Summary

FDA approves Perrigo's abbreviated new drug application for the private-label version of Monistat-1 Combination Pack. Perrigo's OTC Miconazole Nitrate Vaginal Cream and Suppository will ship immediately, the Allegan, Mich.-based private label firm says June 3. Johnson & Johnson/McNeil's Monistat generates about $90 million in annual sales, Perrigo pointed out. Perrigo also said patent litigation by J&J was dismissed, and the approval includes 180 days of generic marketing exclusivity. Analysts with Collins Stewart say the launch of Perrigo's store-brand Monistat product is positive and "gives us greater confidence in [Perrigo's] manufacturing capabilities.

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