NDA Accepted for Quartette for Pregnancy Prevention

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.

For more information call (215) 591-3000 or visit www.tevapharm.com.