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

CHICAGO, Dec. 12/PRNewswire-FirstCall/ --The Female Health Company (NYSE Alternext: FHC) has announced that the U.S. Food and Drug Administration's (FDA) Obstetrics and Gynecology Devices Advisory Committee has unanimously voted that the company's second-generation female condom, the FC2 Female Condom(R), is approvable with a single condition.

The Advisory Committee voted 15-0 that the product is approvable with the condition that the FC2 Female Condom's instructions for use continue to follow use instructions for the FC Female Condom(R) (FC1 Female Condom) and appropriately identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.

The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.

"We are very pleased with today's outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom," said Dr. Mary Ann Leeper, FHC's Senior Strategic Advisor. "We believe that FHC's second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method."

The company filed the FC2 Female Condom Pre-market Approval Application (PMA) with the FDA on January 7, 2008 and has been working with FDA as it reviewed the application.

The company's first-generation FC1 Female Condom received FDA approval for distribution in the United States in 1993. The FC1 Female Condom is also included in the World Health Organization's (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 Female Condoms have been distributed in 142 countries.

The FC2 Female Condom data has been reviewed by other public agencies, including the European Uni
'/>"/>

SOURCE Female Health Company
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists
2. AANMA Provides Commentary to FDA Advisory Committees Reviewing Benefit-Risk Assessment of 12 Hour Bronchodilators
3. New Health Care Advisory Board to Advise PNC on Billing, Payments and Financial Management
4. PharmMD Expands Advisory Board
5. U.S. Labor Secretary Elaine L. Chao announces new membership of OSHA advisory committee
6. Pennsylvania DEP Directs Shadyside Water Supply to Issue Boil Water Advisory
7. Advisory Vote Begins on California Long-Term Care Local
8. Governors Advisory Council on Physical Fitness and Sports Awards Presented by Health
9. Webcast Advisory - The Westaim Corporation Webcast of Conference Call to Discuss 2008 Third Quarter Results
10. Medipacs Appoints Advisory Board Members
11. Skinvisible Appoints Dr. Geert Cauwenbergh to Its International Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/20/2014)... The Advocator Group, LLC is proud ... for Suicide Prevention’s (AFSP) Out of the Darkness walk ... that hosts hundreds of community walks throughout the country ... to help understand and prevent suicide through not only ... , The Advocator Group shares this passion for ...
(Date:10/20/2014)... Women’s health specialist, Dr. Amber Murphy, MD, Ob/Gyn ... Inc., A Division of MaternOhio Clinical Associates, Inc., who ... patients annually. Dr. Murphy will provide a full range ... women’s life. She is accepting new patients at two ... , Dr. Murphy offers a wide variety of services ...
(Date:10/20/2014)... Indianapolis, IN (PRWEB) October 20, 2014 ... Quick Start, a secure cloud solution that enables ... advantage of the ultimate healthcare-specific customer relationship management ... to meet the unique needs of the healthcare ... healthcare experience for providers and patients by combining ...
(Date:10/20/2014)... JZ Fitness, an independently operated wellness ... programming, authorship, international lecturing and community wellness, created by ... release of the JZ Fitness nutrition app, available on ... thousands of individuals on nutrition, Jenn Zerling (“JZ”) has ... require calorie counting or cumbersome food logging. ...
(Date:10/20/2014)... Ohio (PRWEB) October 20, 2014 Principle ... years, takes pride in manufacturing top-of-the-line absorbent products. ... image of its most popular brand, Tranquility® Premium Protection ... created a new website, gave its packaging a new ... bring the brand message to the public. , The ...
Breaking Medicine News(10 mins):Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 2Health News:OhioHealth Welcomes New Women’s Health Specialist to MaternOhio Specialists in Obstetrics & Gynecology of Columbus, Inc. 3Health News:Healthcare Relationship Management (HRM) Leader hc1.com® Launches hc1® Quick Start™ 2Health News:JZ Fitness Nutrition App Launches on iTunes 2Health News:JZ Fitness Nutrition App Launches on iTunes 3Health News:Tranquility® Premium Protection Incontinence Products Releases New Logo and Website 2
... 104 vehicles provide basic healthcare for residents ... of remote areas of Andhra Pradesh,- Innovative healthcare ... Management Research ... Ltd. (NYSE: SAY ), a leading global consulting and information,technology ...
... 26 Particle Sciences Inc. today,announced the ... of drug-eluting polymer medical devices that release ... more. This technology has already been used,by ... rings. "Drug release,from polymeric materials often follows ...
... the Medical Imaging Contrast Agent Association (MICAA), the Council on ... Association (AMIA), will host Medical Imaging Continuum: Path Forward for ... New Biopharmaceutical Products (October 2-3; Bethesda, MD) ... ...
... Industry Leader in Generic Market Information Offers Single Authoritative, ... ... Generics and API Manufacturers, JAKARTA, Indonesia, Aug. 26 /Xinhua-PRNewswire/ ... in,competitive advantage from launch of two solutions in the market ...
... 25 AtriCure, Inc.,(Nasdaq: ATRC ), a medical ... today announced that it will present at the following,investor ... Healthcare Conference at the Four Seasons,Hotel in Boston on ... Executive Officer, is scheduled to present at 10:55,a.m. Eastern ...
... 25 HCA marked its 40th,anniversary during a special ... The event featured HCA Co-Founder and Chairman Emeritus, Dr. ... Bovender, Jr., who spoke about,HCA,s founding, mission and tradition ... "Our History of Caring" program was a,prelude to HCA,s ...
Cached Medicine News:Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 2Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 3Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 4Health News:Satyam Launches Comprehensive, Mobile Healthcare Program for Rural Indians 5Health News:Particle Sciences Develops Zero-Order-Release Combination Device Technology 2Health News:Shaping Best Practices For Standardized Medical Imaging In Clinical Trials 2Health News:Shaping Best Practices For Standardized Medical Imaging In Clinical Trials 3Health News:Indonesia's Pharmaceutical companies Get Boost in Competitive Advantage from Launch of Newport Horizon Premium and IDRAC Solutions by Thomson Reuters 2Health News:Indonesia's Pharmaceutical companies Get Boost in Competitive Advantage from Launch of Newport Horizon Premium and IDRAC Solutions by Thomson Reuters 3Health News:AtriCure to Participate at the Thomas Weisel Partners Healthcare Conference and the UBS Global Life Sciences Conference in September 2Health News:HCA Celebrates 40th Anniversary 2
(Date:10/17/2014)... 2014 ... the addition of the  "China Interventional Cardiovascular ...      (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... China impacted by accelerated ... concept, dietary habit, way of working and ...
(Date:10/17/2014)... , October 17, 2014 ... Imaging Market by Technique (Optical Coherence Tomography, ... software) & by Application (Ophthalmology, Neurology, Oncology, Cardiology) - ... report studies the Optical Imaging market over ... was valued at $917.1 million in 2014 ...
(Date:10/17/2014)... 17, 2014 A victim of medical negligence at ... doctor with a history of alcohol abuse, a physician and ... Prop 46 today, highlighting how Prop 46 will identify and ... The ad pictures a doctor drinking at ... ER."  Proposition 46 will enact the first law in the ...
Breaking Medicine Technology:China Interventional Cardiovascular Device Industry Report 2014-2017 2China Interventional Cardiovascular Device Industry Report 2014-2017 3Optical Imaging Market Worth $1,669.2 Million by 2019 2Optical Imaging Market Worth $1,669.2 Million by 2019 3Optical Imaging Market Worth $1,669.2 Million by 2019 4Victim Of Negligence At Hands Of A Drunk Doctor, A Physician and Consumer Advocates Release New Yes on 46 TV Ad, "On Call" 2Victim Of Negligence At Hands Of A Drunk Doctor, A Physician and Consumer Advocates Release New Yes on 46 TV Ad, "On Call" 3Victim Of Negligence At Hands Of A Drunk Doctor, A Physician and Consumer Advocates Release New Yes on 46 TV Ad, "On Call" 4
... Signature Series multipurpose gamma camera is designed ... The system uniquely combines the high-energy and ... flexibility of modern day SPECT and planar ... maximizes camera performance in PET ...
Sharp diamond shaped double blade in stainless steel....
... AXIOM Artis TA is part ... dynamic and efficient workflow into the ... procedures. On the clinical, technical, functional ... out how AXIOM Artis TA delivers ...
Spring Type with lock. Titanium....
Medicine Products: