Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for Quartette™ (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets). The company is seeking approval to manufacture and market Quartette™, the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy. The NDA was submitted to the FDA on May 31, 2012.
“Quartette™ is an ascending dose regimen oral contraceptive intended for prevention of pregnancy. We looked at when and why breakthrough bleeding occurs and designed Quartette™ to have less disruptive, unscheduled bleeding”
The submission was based on a clinical development program including results from Phase I, Phase II, and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette™ in the prevention of pregnancy. The clinical trials involved more than 3,000 female subjects.
"Quartette™ is an ascending dose regimen oral contraceptive intended for prevention of pregnancy. We looked at when and why breakthrough bleeding occurs and designed Quartette™ to have less disruptive, unscheduled bleeding," said Nancy Ricciotti, senior director of clinical affairs, Teva Women's Health R&D. "Quartette builds upon our heritage in providing women with innovative, extended-cycle contraceptive products and we look forward to the potential to offer the first ascending-dose extended regimen birth-control option."
Women may experience breakthrough bleeding (BTB) with any birth control pill, especially during the first few months. Numerous studies of extended regimens have shown that unscheduled BTB often increases typically during the first few months of treatment. BTB is one of the reasons a large number of women discontinue extended regimens.
Quartette™ is a trademark of Barr Laboratories, Inc.
Teva Pharmaceutical Industries Ltd.