Teva announced that the FDA has accepted its New Drug Application (NDA) for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for pregnancy prevention.
The NDA is supported by results from Phase 1, Phase 2, and Phase 3 clinical trials designed to evaluate the safety and efficacy of Quartette in the prevention of pregnancy. The clinical trials involved ≥3,000 female subjects.
Quartette is the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy.
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