Teva Women's Health, a US-based subsidiary of Teva Pharmaceutical Industries, has announced FDA acceptance of its Quartette new drug application (NDA).
The company is seeking approval to manufacture and market Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy.
Teva Women's Health R&D clinical affairs senior director Nancy Ricciotti said Quartette is an ascending dose regimen oral contraceptive intended for prevention of pregnancy.
"Quartette builds upon our heritage in providing women with innovative, extended-cycle contraceptive products and we look forward to the potential to offer the first ascending-dose extended regimen birth-control option," Ricciotti added.
The submission was based on a clinical development program including results from Phase I, Phase II, and Phase III clinical trials which involved more than 3,000 female subjects and were designed to evaluate the safety and efficacy of Quartette in the prevention of pregnancy.
