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FDA Advisory Committee Votes Unanimously that FC2 Female Condom(R) is Approvable
Date:12/12/2008

CHICAGO, Dec. 12/PRNewswire-FirstCall/ --The Female Health Company (NYSE Alternext: FHC) has announced that the U.S. Food and Drug Administration's (FDA) Obstetrics and Gynecology Devices Advisory Committee has unanimously voted that the company's second-generation female condom, the FC2 Female Condom(R), is approvable with a single condition.

The Advisory Committee voted 15-0 that the product is approvable with the condition that the FC2 Female Condom's instructions for use continue to follow use instructions for the FC Female Condom(R) (FC1 Female Condom) and appropriately identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.

The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.

"We are very pleased with today's outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom," said Dr. Mary Ann Leeper, FHC's Senior Strategic Advisor. "We believe that FHC's second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method."

The company filed the FC2 Female Condom Pre-market Approval Application (PMA) with the FDA on January 7, 2008 and has been working with FDA as it reviewed the application.

The company's first-generation FC1 Female Condom received FDA approval for distribution in the United States in 1993. The FC1 Female Condom is also included in the World Health Organization's (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 Female Condoms have been distributed in 142 countries.

The FC2 Female Condom data has been reviewed by other public agencies, including the European Uni
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SOURCE Female Health Company
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