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
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
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.