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Female Condom Update: IXu Asks Why FDA Dragging Feet, Senator Stabenow Inquires; Cupid Ltd. Offers for Patents

IXu announces it's been waiting three years for a comment from the FDA regarding the FDA's consideration to change standards, allowing other female condoms easier entrance to the market.

IXu CEO Brian Osterberg states, "We're one of only a handful of female condom companies, and the FDA’s 2014 undertaking of the regulatory approval change is the single best chance for other female condoms to get on the U.S. market."

IXu states it can no longer afford to wait business wise, and notes its female condom in a clinical study proved to be substantially equivalent to the single FDA approved female condom on the U.S. market, the FC2.

IXu makes the VA w.o.w Condom Feminine™, an alternative design to the single product which has monopolized the U.S. market for 22 years. The VA w.o.w has been in several EU, South American and African trial markets, including all Portuguese Health Ministry clinics where it became selected by the Ministry over the FC2. New mass-manufacturing capacity developed this year is ready for global distribution.

If and when FDA-approved, IXu is prepared to retail the VA w.o.w consumer-direct for an estimated $1.25 each, with reduced pricing for non-profit organizations. IXu previously sold the VA w.o.w to European distributor Clinifar SA for $.38 cents each wholesale.

IXu requests the FDA reply to U.S. Senator Debbie Stabenow of Michigan who requested information by letter on behalf of IXu on female condom approval changes.

The “highest number ever” of sexually transmitted diseases (STDs) in the U.S. was recently reported by the CDC. Also, the FC2, was recently relegated by its manufacturer to prescription-only or on-line availability, removing it from OTC retail sales.

The VA w.o.w achieved better head-to-head clinical use efficacy results than the FC2. IXu has also invested in bringing condom manufacturing back to the U.S. to help re-industrialize the mid-west.

IXu also announces it will conclude transactions for its female condom patents by November. Cupid Ltd. of India, which produces a knock-off of the VA w.o.w, submitted an offer for the IXu next-gen electronic female condom patents (VA Vibe) and indicated Cupid can contract-manufacture condoms for IXu.

“The basic VA w.o.w Condom Feminine™ is close to full EU availability with stocking commencing to our distributor MIS Healthcare Ltd. of London,” states Osterberg.

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Source: PRWeb
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