FC2 Female Condom approved

12th March 2009

WASHINGTON, March 11 (Reuters) - Female Health Co (FHC.A) has won U.S. approval to market its newer, less expensive female condom, which could help it win over American women as well as boost use in developing countries, the company said on Wednesday.

The company's FC2 Female Condom is made with a softer material for quieter use. Its original version failed to gain a foothold in the male condom-dominated U.S. marketplace in part because it was noisy to use as well as more expensive.

Its new condom is made using a less-costly process that company officials have said should lower its shelf price as well as allow health organizations to distribute more of the birth control device to women in Africa and other areas where AIDS is a major concern.

The approval "is an important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world," Female Health Co's strategic adviser Mary Ann Leeper said in a statement.

Female Health's initial Female Condom was approved in 1993 to prevent pregnancy as well as sexually transmitted diseases but has not been widely used in the United States, which made up just 10 percent of its 34.7 million unit sales in 2008.

The product competes with other birth control methods, most notably male condoms, which can cost as little as 50 cents each amid a variety of competing brands. The original Female Condom costs between $2.80 and $4 a piece.

It was not immediately clear how much the new version would cost or when it would be available. Female Health Co earlier said it was looking for another company to partner with and help market the FC2.

FDA's approval also allows the United States Agency for International Development (USAID) to buy the FC2 Female Condom and distribute it to global programs that aim to prevent the spread of the virus that causes AIDS, the company said.

Dozens of health advocacy groups had urged U.S. approval of the new version, which the company said is already distributed in 77 other countries.

(Reporting by Susan Heavey; Editing by Bernard Orr)

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