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FDA Approves Female Health's Women's Condom


The Female Health Co. announced Wednesday that the U.S. Food and Drug Administration has approved the company's FC2 Female Condom to help protect against pregnancy and sexually transmitted diseases, including HIV/AIDS.

The company said the lower-cost second generation female condom will now be available for purchase in the U.S. FDA approval will also allow the United States Agency for International Development to procure the condoms and distribute them to global HIV/AIDS programs.

FHC's first-generation FC Female Condom was originally approved by the FDA in 1993. Since then, the company said the first-generation condoms have been distributed by United Nations agencies in 142 countries.

The company said it began developing the second-generation condom five years ago in an attempt to expand its access to women by significantly lowering the cost. FHC said it has successfully reduced the cost by as much as 30 percent by using a new material and a highly automated manufacturing process.

The company said studies have shown that FC2 performs in a comparable manner to the first-generation product.

"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," said Mary Ann Leeper, FHC's senior strategic adviser.

The World Health Organization reviewed the scientific data and cleared the second-generation condom for purchase by UN agencies in 2006, FHC said. Since then, more than 23 million FC2 Female Condoms have been distributed in 77 countries.


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Information in this article was accurate in March 11, 2009. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.