Teva Women's Health, Inc. (TEVA) Receives FDA Acceptance of Its New Drug Application for Quartette™ (Levonorgestrel/Ethinyl Estradiol Tablets and Ethinyl Estradiol tablets) for the Prevention of Pregnancy
8/13/2012 9:51:40 AM
FRAZER, Pa.--(BUSINESS WIRE)--Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for Quartette™ (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets). The company is seeking approval to manufacture and market Quartette™, the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy. The NDA was submitted to the FDA on May 31, 2012.