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US green light for Teva birth control pill

Daily News | April 02, 2013

Kevin Grogan

US green light for Teva birth control pill

The US Food and Drug Administration has approved Teva Pharmaceutical Industries' Quartette, which the Israeli company describes as "the next generation of extended-regimen oral contraceptives".

The green light has been given to Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets which are designed to minimise breakthrough bleeding (BTB) between scheduled periods. The approval is principally based on data from a Phase III trial, which involved more than 3,000 women and found the drug was 97% effective at preventing pregnancy.

The company quoted James Simon, professor of obstetrics and gynaecology of the George Washington University School of Medicine, as saying that BTB "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". He explained that the oestrogen in Quartette increases at specific points "and provides four short light periods a year", adding that BTB decreases over time, "which might help encourage patient adherence.”

Jill DeSimone, head of Teva's women's health business, said Quartette is "a uniquely differentiated product…and is an example of our dedication to providing a variety of contraceptive and family planning options".

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