Today Sponge
This article was originally published in The Tan Sheet
Executive Summary
Contraceptive sponge could be on market late this year if the agency clears Allendale Pharmaceuticals production systems in a promised July 10 response to its manufacturing review, the firm says. Allendale notes the agency's upcoming reply may be neither positive nor definitive, but points out "this is the first time [FDA] has given us a firm date." The manufacturer has met with FDA several times over the last six months. The Sponge was approved for use in Canada last year (1"The Tan Sheet" March 10, 2003, In Brief). In an effort to expand the Today brand, Allendale acquired an "all-natural" insert product "that helps maintain vaginal pH levels by introducing vitamin C into the vaginal environment." The product has been sold in Europe for the last few years; it should reach the U.S. market in January...