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FRAZER, Pa. — The Food and Drug Administration is reviewing a regulatory application from Teva for a contraceptive drug, the company said Monday.
Teva Women's Health, part of Israeli drug maker Teva Pharmaceutical Industries, announced the FDA's acceptance of its application for Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol), which the company called the first ascending-dose, extended regimen oral contraceptive for preventing pregnancy.
"Quartette is an ascending-dose regimen oral contraceptive intended for prevention of pregnancy," Teva Women's Health R&D senior director of clinical affairs Nancy Ricciotti said. "We looked at when and why breakthrough bleeding occurs and designed Quartette to have less disruptive, unscheduled bleeding."
Breakthrough bleeding is a side effect that often occurs in women taking birth control pills, increasing during the first few months of treatment, and is one of the reasons why a large number of women discontinue extended regimens.