The Female Health Company Announces FDA Acceptance for Review of Its FC2 Premarket Approval Application
06 Februar 2008 - 2:30PM
PR Newswire (US)
CHICAGO, Feb. 6 /PRNewswire-FirstCall/ -- The Female Health Company
(AMEX:FHC) today announced that the Food and Drug Administration
(FDA) has determined that the Premarket Approval Application (PMA)
it submitted for its second generation product, FC2 female condom,
has been accepted for review. The Center for Devices and
Radiological Health (CDRH) received FHC's PMA on January 8, 2008.
About The Female Health Company, Inc. The Female Health Company,
based in Chicago, Illinois, manufactures and markets the FC Female
Condom(R), which is primarily distributed by public health
organizations and donor groups in over 90 developing countries
around the world. World-wide, the Female Condom is available in
various programs in 108 countries. The Company owns certain
worldwide rights to the FC Female Condom(R), including patents that
have been issued in the United States, United Kingdom, Japan,
France, Italy, Germany, Spain, the European Patent Convention, the
People's Republic of China, Canada, South Korea and Australia. FC
Female Condom(R) is the only available FDA-approved product
controlled by a woman that offers dual protection against sexually
transmitted diseases, including HIV/AIDS, and unintended pregnancy.
"Safe Harbor" statement under the Private Securities Litigation
Reform Action of 1995: The statements in this release which are not
historical fact are forward-looking statements based upon the
Company's current plans and strategies, and reflect the Company's
current assessment of the risks and uncertainties related to its
business, including such things as product demand and market
acceptance; the economic and business environment and the impact of
government pressures; currency risks; capacity; efficiency and
supply constraints; 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 the Company's operations may vary from
those currently anticipated. For more information about the Female
Health Company visit the Company's web site at
http://www.femalehealth.com/ and http://www.femalecondom.org/. If
you would like to be added to an e-mail alert list, please send an
e-mail to DATASOURCE: The Female Health Company CONTACT: William R.
Gargiulo, Jr., +1-231-526-1244, or Donna Felch, CFO,
+1-312-595-9123, both of The Female Health Company Web site:
http://www.femalehealth.com/ http://www.femalecondom.org/
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