The Female Health Company Announces FDA Acceptance for Review of Its FC2 Premarket Approval Application
Posted on: Wednesday, 6 February 2008, 12:00 CST
CHICAGO, Feb. 6 /PRNewswire-FirstCall/ -- The Female Health Company 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 FHCInvestor@femalehealthcompany.com
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/
Source: PRNewswire-FirstCall
Related Articles
- The Female Health Company / HLL Lifecare Limited Receive National AIDS Control Organization of India Order for 1.5 Million FC2 Female Condoms
- The Female Health Company to Expand Manufacturing Capacity for FC2 Female Condom By 150%
- The Female Health Company Schedules Conference Call to Discuss FDA Approval of FC2 Female Condom(R) for March 12, 2009
- Female Health Company Receives FDA Approval for FC2 Female Condom(R)
- The Female Health Company Receives USAID | DELIVER PROJECT Order for 8.1 Million Units
- The Female Health Company Receives USAID | DELIVER PROJECT Order for 5 Million Units
- Female Health Company Appoints Robert Nelson Director, Program and Sales
- The Female Health Company Receives Total USAID Orders Exceeding 8.5 Million Units for 2006; USAID Exercises Contract Option for Incremental Volume
- Female Health Company Names Donna Felch Chief Financial Officer
 |
 |
User Comments (0)
RSS Feeds