US FDA approves Teva's oral contraceptive Quartette

2 April 2013

There was good news for Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) when the US Food and Drug Administration has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy.

Quartette represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize breakthrough bleeding (BTB) between scheduled periods.

“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,” said James Simon, clinical professor of Obstetrics and Gynecology at the George Washington University School of Medicine quoted by Teva. “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,” he explained.

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