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.