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FDA Advisory Committee Votes Unanimously that FC2 Female Condom(R) is Approvable
Date:12/12/2008

on, India, Brazil and the World Health Organization (WHO). In 2006, the WHO agreed that the FC2 Female Condom does perform in the same manner as the FC1 Female Condom and recommended that the FC2 Female Condom can be purchased by UN agencies. Since then, over 22 million FC2 female condoms have been distributed in 77 countries.

Performance of FC2 Female Condom in Clinical Trial

FHC presented data from a randomized, double-blind, crossover, comparative trial with the FC1 Female Condom. The FC1 Female Condom is currently distributed in over 100 countries, including the U.S. 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 clinical trial was conducted in 2004 by the Reproductive Health and HIV Research Unit of the University of Witwatersrand in South Africa. Over 200 women participated in the study. The results of the study showed that the FC2 Female Condom is safe and that the risk of failure during use was equivalent to FC1. Results from the study were originally published in the journal Contraception. (See Contraception 73 (2006) 386- 393.)

Unintended Pregnancy and HIV/STI Transmission in the U.S.

Unintended pregnancy and the transmission of HIV and other STIs remain significant public health challenges in the U.S. According to the Centers for Disease Control and Prevention (CDC), approximately one-half of pregnancies in the U.S. were unintended in 2001, and contraception methods provided by federally funded family planning programs (male condoms, female condoms, the Pill, and IUDs) prevent an estimated 1.3 million unintended pregnancies each year.

Over the past two decades, the proportion of women among all people living with HIV/AIDS (PLHIV) in the U.S.
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SOURCE Female Health Company
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