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Female Health Company Receives FDA Approval for FC2 Female Condom(R)
Date:3/11/2009

gher among Hispanic women than among Caucasian women.

"Nearly three decades after the start of the global AIDS pandemic, FHC's female condoms remain the only safe and effective woman-initiated HIV prevention method approved by the FDA," said Dr. Mary Ann Leeper, FHC's senior strategic advisor. "Today's approval of FC2--a lower-cost, second-generation female condom--is an important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world."

FHC's first-generation FC Female Condom(R) (FC1) originally received FDA approval for distribution in the United States in 1993. FC1 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.

Introduction of a More Cost-Effective Manufacturing Process

The cost of FC1 has remained a key barrier to increased uptake by HIV prevention programs in the U.S. and globally. While numerous studies over the past two decades have indicated that acceptability of FC1 is comparable to the male condom among both male and female users, the high cost of FC1 has limited procurement by government programs and direct purchase by individual consumers.

This cost factor has reduced public access to the only safe and effective woman-initiated method of HIV and STI prevention developed since the start of the global AIDS pandemic. It is estimated that the annual global public sector male condom market is approximately 10 billion units versus about 35 million Female Condoms distributed in FY 2008. This suggests a remarkable opportunity for the Female Condom to strengthen access to HIV/AIDS prevention tools through increased access to the only woman-initiated prevention method.

As a result, five years ago FHC initiated the
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SOURCE The Female Health Company
Copyright©2009 PR Newswire.
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