CHICAGO The Female Health Company on Friday announced that the Food and Drug Administration’s Obstetrics and Gynecology Devices Advisory Committee unanimously voted that the company’s second-generation female condom, the FC2 Female Condom, is approvable for sale over-the-counter provided that the FC2 Female Condom's instructions for use continue to follow use instructions for the FC Female Condom and identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.
“We are very pleased with today’s outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom,” said Mary Ann Leeper, FHC’s Senior Strategic Advisor. “We believe that FHC’s second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method.”
The FC2 Female Condom, which looks very similar to the FC1 Female Condom, was developed to expand access to women at risk of HIV and STIs by lowering the cost of the product through the introduction of a more efficient manufacturing process.
The company’s first-generation FC1 Female Condom received FDA approval for distribution in the United States in 1993.
The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.