FDA approves new nitrile female condom

ERJ staff report (RD)

Washington - The US Food and Drug Administration (FDA) has granted approval to the FC2 female condom - a lower cost, second-generation product made from nitrile synthetic rubber. Earlier models were made from polyurethane.

The FC2 is manufactured by the Female Health Company to combat HIV infections, an 11 Mar company statement said.

The Female Health Company emphasised the importance of FDA approval as the FC2 will be around 30 percent cheaper than its predecessor, the FC1. The female condom is currently the only method available to prevent HIV infection and unintended pregnancy that is designed for women's initiation, the company said.

The FC2 has the same design, appearance and use as the FC1, but is made from the synthetic rubber, nitrile. The FC2 holds all the benefits of the FC1 and is comparable in safety and effectiveness, the company said.

"We join women around the world in applauding the FDA's swift action to approve the FC2 female condom," stated Serra Sippel, executive director of the Center for Health and Gender Equity. "The HIV pandemic among women requires increased investment in woman-centered prevention options, and FC2 approval is an important step forward in putting the power of prevention in women's hands."

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Press release from The Female Health Company