PEDIASTAT (miconazole nitrate, USP 0.25%), Diaper Rash Ointment NDA 21-026

Johnson & Johnson Consumer Companies Inc

Disclaimer

Cover Letter

Table of Contents

Introduction/Background

PEDIASTAT Indication/Description/Dosing

Efficacy

Safety

Marketing History

Microbiology

Diaper Dermatitis - Clinical Practice

The Case for PEDIASTAT

Conclusions

Appendix A - Tables

Appendix B - Reference Letters

Appendix C - Bibliography

FDA Background Materials

Cover Letter & Summary

Attachment 1 Skin Protectant Drug Products for OTC Human Use; Diaper Rash Drug Products Proposed Rule (55FR25229 6/20/90)

Attachment 2 - Topical Antifungal Drug Products for OTC Human Use; Diaper Rash Labeling Claims; Final Rule (57FR60430 12/18/92)

Attachment 3

Attachment 4 Minutes of pre-NDA meeting for IND

Attachment 5 Non-Approval Letter of 1999 for NDA 21-026

Attachment 6 Proposed Label for J&J's Miconazole Nitrate Ointment 0.25% (submitted 3/28/00)

Attachment 7 Antifungal drug resistance in Candida albicans by TC White*

Attachment 8 Clinical, cellular and molecular factors that contribute to antifungal drug resistance by TC White, KA Marr and RA Bowden*

Attachment 9 Characterisation of yeasts implicated in vulvovaginal candidosis in Irish women N al-Rawi and K Kavanagh

Attachment 10 Emergence of resistance of Candida albicans to clotrimazole in human immunodeficiency virus-infected children: in vitro and clinical correlations by R Pelletier, J Peter, C Antin, C Gonzalez, L Wood and TJ Walsh*

Attachment 11 Systyemic candidiasis in extremely low birth weight infants receiving topical petrolatum ointment for skin care: a case-control study by JR Campbell, E Zaccaria and CJ Baker*

Microbiology Summary

*Copyrighted material.  This material may be viewed at:  Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.