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FDA Approves New Drug Application For Teva Pharmaceutical Industries Ltd's Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets For Prevention Of Pregnancy


Friday, 29 Mar 2013 08:00am EDT 

Teva Pharmaceutical Industries Ltd announced that the U.S. Food and Drug Administration (FDA) 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 bleeding (BTB) between scheduled periods. The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette. The Phase III clinical trial, which involved more than 3,000 women, found that Quartette was 97% effective at preventing pregnancy. Data further demonstrated that the common adverse reactions (≥2%) in the Phase III clinical trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting, acne, dysmenorrhea, weight increased, 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.