CHICAGO, Feb. 6 The Female Health Company(Amex: FHC) today announced that the Food and Drug Administration (FDA) hasdetermined that the Premarket Approval Application (PMA) it submitted for itssecond generation product, FC2 female condom, has been accepted for review.The Center for Devices and Radiological Health (CDRH) received FHC's PMA onJanuary 8, 2008.
About The Female Health Company, Inc.
The Female Health Company, based in Chicago, Illinois, manufactures andmarkets the FC Female Condom(R), which is primarily distributed by publichealth organizations and donor groups in over 90 developing countries aroundthe world. World-wide, the Female Condom is available in various programs in108 countries. The Company owns certain worldwide rights to the FC FemaleCondom(R), including patents that have been issued in the United States,United Kingdom, Japan, France, Italy, Germany, Spain, the European PatentConvention, the People's Republic of China, Canada, South Korea and Australia.FC Female Condom(R) is the only available FDA-approved product controlled by awoman that offers dual protection against sexually transmitted diseases,including HIV/AIDS, and unintended pregnancy.
"Safe Harbor" statement under the Private Securities Litigation ReformAction of 1995: The statements in this release which are not historical factare forward-looking statements based upon the Company's current plans andstrategies, and reflect the Company's current assessment of the risks anduncertainties related to its business, including such things as product demandand market acceptance; the economic and business environment and the impact ofgovernment pressures; currency risks; capacity; efficiency and supplyconstraints; and other risks detailed in the Company's press releases,shareholder communications and Securities and Exchange Commission filings.Actual events affecting the Company and the impact of such events on theCompany's operations may vary from those currently anticipated.
For more information about the Female Health Company visit the Company'sweb site at http://www.femalehealth.com and http://www.femalecondom.org.
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SOURCE The Female Health Company