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REALITY FEMALE CONDOM SCHEDULED FOR FDA ADVISORY PANEL REVIEW

 REALITY FEMALE CONDOM SCHEDULED FOR FDA ADVISORY PANEL REVIEW
 JACKSON, Wis., Oct. 28 -- WISCONSIN PHARMACAL COMPANY, INC. announced that it has been advised that its pre-market approval application (PMA) and supplements for the REALITY female condom will be reviewed at a Dec. 10-11, 1992, meeting of the Food and Drug Administration's Obstetrics-Gynecology Devices Advisory Panel. REALITY is a barrier device worn by women to reduce the risk of unintended pregnancy and sexually transmitted diseases such as AIDS.
 The PMA for REALITY was submitted on Oct. 29, 1991. At a Jan. 31, 1992 meeting of the Devices Advisory Panel, the panel unamimously recommended that FDA approve REALITY contingent on the completion of a pregnancy efficacy study and the provision of certain other data. The information required, including the results of the pregnancy study, was submited as a PMA supplement to FDA on July 31, 1992.
 The company is pleased with the prompt scheduling by FDA of the panel meeting. However, there is no guarantee the product will be approved.
 To date, REALITY has been clinically tested at 71 medical centers, hospitals and clinics in 10 countries worldwide. These tests have involved more than 1,700 couples and over 30,000 uses of the barrier device. One major study, the pregnancy effectiveness study, was sponsored by the United States Agency for International Development (USAID), and implemented by Family Health International (FHI) and the Contraceptive Research and Development Agency (CONRAD).
 Based in Jackson, the WISCONSIN PHARMACAL COMPANY has the exclusive rights to market REALITY in the United States, Canada and Mexico. The company, or a corporate partner, will market and distribute REALITY, once it is approved by the FDA, under a license from Chartex International Plc, a British health care company which owns the worldwide rights to the product. WISCONSIN PHARMACAL will be the initial manufacturer of REALITY. However, due to the volume required, Chartex will be the principal manufacturer once their facility is inspected and approved by the FDA.
 Outside the United States and Canada, REALITY is marketed as femidom. To date, femidom is available in Switzerland and the United Kingdom.
 -0- 10/28/92
 /CONTACT: John A. Wundrock, president and CEO, 414-677-4121 (company information), or Dr. Mary Ann Leeper, senior vice president- development, 312-280-8541 (REALITY (R) product information)/
 (WPCI) CO: Wisconsin Pharmacal Company, Inc. ST: Wisconsin IN: MTC SU:


SM -- NY126 -- 6273 10/28/92 17:19 EST
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Publication:PR Newswire
Date:Oct 28, 1992
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