Updated on 1 April 2013
Pregnant no more - Teva extended oral contraceptive Quartette gets FDA nod
Singapore: The US FDA has approved Teva Pharmaceutical's Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette represents extended regimen oral contraceptives to be approved by the FDA and was designed to minimize breakthrough bleeding (BTB) between scheduled periods.
Dr James A Simon, clinical professor, Obstetrics and Gynecology, George Washington University School of Medicine, US, said that, "Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens. 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."
Mr Jill DeSimone, senior vice president and general manager, Global Teva Women's Health, said that, "Teva is the leader in the pharmaceutical industry in the marketing and development of extended regimen oral contraceptives, and Quartette represents the next generation of these contraceptives. It is a uniquely differentiated product and is based on Teva's research into when breakthrough bleeding is most likely to occur with these regimens. 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."