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Today Sponge in Canada

This article was originally published in The Tan Sheet

Executive Summary

First shipment of contraceptive devices to Canada is underway after nearly $1 mil. in investments to meet GMP standards, according to Allendale Pharmaceuticals. Canadian brick-and-mortar retailers such as Wal-Mart, Shoppers Drug Mart, PharmaPlus should have Today Sponge by April 1, while three online retailers were expected to begin selling product March 1, Allendale says. Firm anticipates it is still roughly nine months away from U.S. distribution, as it has yet to complete six-month stability studies and host FDA plant inspection...

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OTC Drug Facts labeling for contraceptive sponge approved by FDA Nov. 3; packaging was last updated in 1994, Allendale Pharmaceuticals says. Agency has all information on stability tests, drug chemistry needed to make a decision on approval. The firm hopes to hear from FDA by the end of February. The Sponge has been available in Canada since March 2003 (1"The Tan Sheet" March 10, 2003, In Brief)...

Today Sponge

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...

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