Female Health announces approvals for marketing its second-generation female condom
CHICAGO The Female Health Company on Friday announced that the Food and Drug Administration’s Obstetrics and Gynecology Devices Advisory Committee unanimously voted that the company’s second-generation female condom, the FC2 Female Condom, is approvable for sale over-the-counter provided that the FC2 Female Condom’s instructions for use continue to follow use instructions for the FC Female Condom and identify the study that was performed to establish the comparable safety and effectiveness of FC2 with FC1.
“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 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 FC2 Female Condom, which looks very similar to the FC1 Female Condom, was developed to expand access to women at risk of HIV and STIs by lowering the cost of the product through the introduction of a more efficient manufacturing process.
The company’s first-generation FC1 Female Condom received FDA approval for distribution in the United States in 1993.
The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing obstetric and gynecologic devices.
Mexican product released in U.S. may prevent erectile dysfunction
SAN FRANCISCO Hispanic men between the ages of 20 and 50 are two and a half times as likely as men of other races and ethnicities to develop erectile dysfunction, according to a study published in the Archives of Internal Medicine in 2005.
A product on the market in Mexico since 2004 and recently introduced in the United States might address the problem. CRB Ventures said the product, The Sensual Tea, has a rate of effectiveness of 87.3 percent in treating erectile dysfunction and premature ejaculation and has no side effects.
“It is possible to prevent sexual problems from ever occurring,” CRB Ventures president Christian Beasley said in a statement. “The Sensual Tea overcomes low libido and sexual fatigue and enhances the pleasure and intensity of sex.”
CRN announces second year of ‘Life … supplemented’ educational campaign
WASHINGTON The Council for Responsible Nutrition today announced that its “Life … supplemented” nutritional supplement awareness campaign is continuing for the second year, will be supported by physicians as spokespeople, and that recent study results showed that more healthcare professionals recommend patients take supplements—and take supplements themselves.
Results of the 2008 Healthcare Professionals Impact Study, an overview of attitudes on supplement use by cardiologists, dermatologists and orthopedics, revealed that professionals in these healthcare fields recommend and also use dietary supplements for wellness and enhanced health. The study also said that practitioners in these fields believe supplement use has gone more mainstream than five years ago.
Of orthopedic specialists, 73 percent said that they take supplements and 91 percent said that they recommend supplements to their patients. Of the pool of cardiologists, 57 percent said that they regularly take supplements and 72 percent reported that they recommend them to their patients. And, 79 percent of the dermatologists surveyed said they take supplements, and 66 percent said that they recommend them.
The survey pool included 300 specialists from each field with a margin of error of 3.3 percent.
CRN has also named three healthcare professionals who will serve as spokespeople for the “Life … supplemented” campaign. Jeannette Graf, a dermatologist based in New York, cardiothoracic surgeon William Cooper of Emory University and UCLA orthopedic specialist Nick Shamie will speak on behalf of the benefits of supplements.
“We learned from the 2007 HCP Impact Study that physicians and nurses are taking supplements as part of a proactive wellness regimen that also includes healthy diet and regular exercise,” Judy Blatman, senior vice president of communications at CRN said. “With the second year of this study, we were able to dive into specific specialties and find similar trends, further demonstrating the important role for doctors in incorporating dietary supplements as an integral part of wellness.”
The 2008 study followed a similar 2007 HCP Impact study conducted by CRN which concluded about 72 percent of physicians and 89 percent of nurses use dietary supplements themselves. Of the physicians, 79 percent and 82 percent of the nurses involved in that survey said they recommend dietary supplements to patients.