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FDA Approves Teva's New Drug Application For Oral Contraceptive Quartette

Generic drugmaker Teva Pharmaceutical Industries Ltd. (TEVA) Friday said the U.S. Food and Drug Administration or FDA has approved Quartette, or levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets for prevention of pregnancy.

The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette.

The Phase III clinical trial, which involved more than 3,000 women, found that Quartette was 97 percent effective at preventing pregnancy.

According to the Israel-based company, Quartette represents the next generation of extended regimen oral contraceptives to be approved by the FDA. The product was designed to minimize breakthrough bleeding between scheduled periods.

"Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens," said James Simon, clinical professor of Obstetrics and Gynecology at the George Washington University School of Medicine.

The estrogen in Quartette increases at specific points and provides four short light periods a year, Teva noted.

Quartette features a unique 91-day oral regimen, whereby the dose of estrogen increases at three distinct points over the first 84 days and the amount of progestin remains consistent. This is followed by seven days of 10 mcg of ethinyl estradiol.

TEVA closed Thursday's regular trading at $39.68, up 0.46 percent, on a volume of 4.16 million shares on the NYSE.

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