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Teva Says Positive Phase 3 Results on Quartette

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Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced the findings from a Phase III pivotal trial of QuartetteTM (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), an investigational ascending-dose, extended-regimen oral contraceptive for the prevention of pregnancy that is currently under review by the U.S. Food and Drug Administration. These data were presented for the first time as a poster at the 68th Annual Meeting of the American Society of Reproductive Medicine (ASRM).

The Phase III, multicenter, open-label, single arm study evaluated the efficacy and safety of QuartetteTM over one year; 3,701 sexually active women 18 to 40 years old were enrolled and 2,144 completed the study. Data demonstrated QuartetteTM is efficacious for the prevention of pregnancy and has a safety profile similar to that of other oral contraceptives.1

Posted-In: News FDA


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