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FDA Approves Teva Pharma's NDA For Quartette Contraceptives - Quick Facts

Teva Pharmaceutical Industries Ltd. (TEVA) announced the FDA has approved Quartette tablets for the prevention of pregnancy. The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials. The Phase III clinical trial, which involved more than 3,000 women, found that Quartette was 97 percent effective at preventing pregnancy, the company said.

Quartette features a 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.

by RTT Staff Writer

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