Teva Pharmaceuticals announced that the FDA has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette, an extended oral contraceptive regimen, was designed to minimize breakthrough bleeding between scheduled periods.
Quartette features a 91-day oral regimen, where 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 ethinyl estradiol 10mcg.
The approval was based on a development program that included results from Phase 1, 2, and 3 clinical trials evaluating the safety and efficacy of Quartette. Results from the Phase 3 clinical trial, which involved over 3,000 women, found that Quartette was 97% effective at preventing pregnancy. In addition, breakthrough bleeding and unscheduled spotting decreased over successive 91-day cycles.
For more information call (888) TEVA-USA or visit www.tevapharm.com.