Teva wins FDA approval for oral contraceptive

Quartette has been designed by Teva to minimize breakthrough bleeding between scheduled periods.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that the US Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) contraceptive tablets.

Quartette has been designed to minimize breakthrough bleeding (BTB) between scheduled periods. The approval boosts Tevas decision to focus on an innovative range of women's health pharmaceutical products.

George Washington University School of Medicine clinical professor of Obstetrics and Gynecology Dr. James A. Simon said, 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.

Approval follows a Phase III clinical trial that involved more than 3,000 women. The trial found that Quartette was 97% effective at preventing pregnancy. Data showed that the most common negative side effects (less than 2%) in the Phase III clinical trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight gain, mood changes, anxiety/panic attack, breast pain and migraines. The primary clinical trial that evaluated the efficacy of Quartette also assessed BTB. BTB and unscheduled spotting decreased over successive 91 day cycles.

Quartette involves a 91-day oral regimen where the estrogen dose increases at three distinct points over the first 84 days and the amount of progestin remains consistent, followed by seven days of 10 mcg of ethinyl estradiol.

Senior vice president & general manager, Global Teva women's health Jill DeSimone said, Quartette is a uniquely differentiated product and is based on Tevas research into when breakthrough bleeding is most likely to occur with these regimens."

Published by Globes [online], Israel business news - www.globes-online.com - on March 29, 2013

Copyright of Globes Publisher Itonut (1983) Ltd. 2013

 
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