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.”
OTC sleep aids get boost from boomers
NEW YORK The market for OTC sleep aids is thriving, thanks in large part to baby boomers, according to a recent research report.
A new report by market research publisher Packaged Facts estimates that the total OTC market for sleep aids alone reached $604 million in 2008, an increase of 9 percent compared with $533 million in 2007. The increase was on par with the 8 percent compound annual growth rate that OTC sleep aids experienced between 2004 and 2008.
Both short-term and long-term success of the market is tied to aging baby boomers, a high-income populace less likely to feel the economic crunch as strongly as consumers with more moderate levels of income, the report states.
Furthermore, women of the baby boomer generation tend to face unique sleep challenges. As women age, more than half entering their menopausal transition years can expect to experience various primary sleep disorders, including sleep apnea, snoring, restless legs syndrome or insomnia.
“Sleep disorders are under-diagnosed in menopausal women, and many experts now recommend special consideration when diagnosing and treating their sleep problems,” stated Tatjana Meerman, publisher of Packaged Facts.