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March 12, 2009

New Female Condom Approved by FDA

The U.S. Food and Drug Administration has approved the Female Health Co. (FHC) FC2 Female Condom to aid protection against unwanted pregnancy and sexually transmitted infections including HIV, The Associated Press reports.

The lower-cost second-generation female condom will now be sold in the United States, according to the FHC. In addition, the FDA approval will allow the U.S. Agency for International Development to obtain and distribute the condoms to global HIV/AIDS programs. The FDA originally approved FHC’s first-generation FC Female Condom in 1993, when it was distributed in only 142 countries.

Studies have shown that the FC2 performs in a comparable manner to the first-generation product, but the second-generation condom is 30 percent cheaper due to a new material and an automated manufacturing process.

“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.

Search: female condom, FDA


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