The US FDA has approved Teva Pharmaceutical Industries' new drug application (NDA) for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets as oral contraceptives.
Quartette, designed as next generation of extended regimen oral contraceptives, will reduce breakthrough bleeding (BTB) between scheduled periods.
Because of the 91-day oral regimen, an increase in estrogen dose occurs at three distinct points over the first 84 days while the progestin amount remains constant.
For a seven-day period, 10mcg of ethinyl estradiol is followed.
The George Washington University School of Medicine obstetrics and gynecology clinical professor Dr. James Simon said, "The estrogen in Quartette increases at specific points and provides four short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence."
The NDA included positive data from Phase I, Phase II and Phase III clinical trials that assessed Quartette's safety and efficacy profile.
Global Teva Women's Health senior vice president and general manager Jill DeSimone said, "Quartette is the newest product in our global women's health franchise and is an example of our dedication to providing a variety of contraceptive and family planning options that fit women's lifestyles."
