Teva Receives FDA Acceptance of Its New Drug Application for Quartette(tm) (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for the Prevention of Pregnancy.

UNITED States. Food & Drug Administration; TEVA Women's Health Inc.; ORAL contraceptives; CLINICAL trials; MARKETING; BIRTH control

The article informs that the U.S. Food & Drug Administration (FDA) has accepted for filing of a New Drug Application (NDA) by Teva Women's Health Inc. for Quartette. It informs that the company is seeking approval to manufacture and market Quartette which is the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy. It reports that the submission was based on a clinical development program including results from clinical trials of the drug.