July 12, 2000

Labeling Issues on the Today Sponge (NDA 18-733)

Allendale Pharmaceuticals


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.

Allendale Pharmaceuticals

Vaginal Contraceptive Sponge, Elizabeth B Connell MD, Emory University School of Medicine

Talk Paper, Today Sponge, T95-1, Jan. 12, 1995

Toxic Shock Syndrome Overview, Andrew B Onderdonk PhD, Brigham and Women's Hospital, Harvard Medical School

Michael S Burnhill, MDDMSc, Planned Parenthood, June 7, 2000

       Food and Drug Administration

Table of Contents

Executive Summary

1991 Label Submission

2000 Label Submission

PostMarketing Safety Review

Medical Review

May 1983 Citizen Petition

June 1983 Citizen Petition

February 1992 Citizen Petition

FDA Response August 1997

April 24, 2000 Citizen Petition