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.”
Valeant pays $285 million for derm drug maker
ALISO VIEJO, Calif. Valeant Pharmaceuticals has agreed to buy Dow Pharmaceutical Sciences—which makes drugs to treat acne and other skin conditions, primarily for other pharmaceutical companies—for $285 million, according to several reports.
The deal, set to close in the next few weeks, considerably expands Valeant’s presence in the dermatological space.
The privately held Dow Pharmaceutical Sciences—no connection to Dow Chemical—recently received FDA approval for a new prescription topical acne medication, Acanya, which is expected to hit the market early next year and is projected to reach sales of $70 million.
Valeant also will inherit the rest of Dow’s considerable new product development pipeline, including several other drugs for treating rosacea, fungal infections and warts.
The Dow acquisition comes close on the heels of Valeant’s November purchase of Australian skin care remedy maker DermaTech Pty Ltd., for a little more than $12 million. DermaTech makes drugs for treating acne, psoriasis, warts, head lice and nits, both prescription and OTC.
Analysts are regarding the recent moves as a bit of a “turnaround story,” for the northern California-based company formerly known as ICN Pharmaceuticals, which last year reemerged as Valeant Pharmaceuticals following a considerable restructuring.