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Monistat 3 NDA approval

This article was originally published in The Tan Sheet

Executive Summary

J&J Monistat 3 Combination Pack label changes "to include additional instructions for disposable vaginal suppository applicators" approved by FDA Jan. 9. Approval letter for supplemental NDA 20-670/S-011 also contains labeling recommendations for both reusable and disposable applicator forms, which should be implemented at the next printing, FDA says. Advised changes include revising "declaration of net quantity of contents to distinctly identify both products within the package," modifying product name to reflect USP name for miconazole nitrate vaginal suppositories and various minor changes to the "Drug Facts" panel to reflect the OTC labeling final rule, agency notes...
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