June 30, 2000

Briefing Information

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

Johnson & Johnson Consumer Companies Inc


The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Cover Letter

Table of Contents


PEDIASTAT Indication/Description/Dosing



Marketing History


Diaper Dermatitis - Clinical Practice

The Case for PEDIASTAT


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.