CHICAGO (March 12, 2009)—The U.S. Food and Drug Administration has granted the Female Health Co. regulatory approval for the FC2 female condom, the second generation of the device the FDA first approved in 1993.
FDA approval means the device may now be distributed in the U.S. and purchased by the U.S. Agency for International Development for distribution in AIDS/HIV prevention programs worldwide.
The FC2 has the same design and appearance as the FC1 and is used the same way, according to the Chicago-based Female Health Co., manufacturer of the device. However, the FC2 is made of nitrile rubber instead of the FC1's polyurethane, cutting the cost by about 30 percent. A lower price for the device is important in the effort to get it to women in the Third World who need HIV protection, the company said.
The day before the FDA approved the FC2, FHC announced it would add six production lines for the device at its production facility in Malaysia, increasing production to 75 million to 80 million units annually from the current 30 million.