Teva’s Quartette data support US filing

Teva Women’s Health has reported Phase III clinical data for its novel, dose-ascending extended-regimen oral contraceptive Quartette. The new product, which contains levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets, is currently under review at the US FDA after being accepted for review in August, and is the first dose-ascending oral contraceptive.

Teva Women’s Health has reported Phase III clinical data for its novel, dose-ascending extended-regimen oral contraceptive Quartette. The new product, which contains levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets, is currently under review at the US FDA after being accepted for review in August, and is the first dose-ascending oral contraceptive.

The results, presented this week at the American Society of Reproductive Medicine in San Diego, are from a 2,144-patient open-label Phase III study. Efficacy in the study was measured using...

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