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Barrier Therapeutics To Submit Amended J&J Miconazole Diaper Rash NDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Barrier plans to submit the application by year-end, seeking a narrower indication than the original Johnson & Johnson NDA. Barrier's Phase III study of Zimycan in Candida-associated diaper dermatitis was designed to address FDA concerns over the scope and definition of the non-specific diaper dermatitis indication J&J had pursued for the ointment, then called Pediastat.

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