US FDA accepts Teva's Quartette NDA
The US Food and Drug Administration has accepted for filing the New Drug Application for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets), filed by Teva Women’s Health, a US subsidiary of Israel’s Teva Pharmaceutical Industries (Nasdaq: TEVA) on May 31.
The company is seeking approval to manufacture and market Quartette, the first ascending-dose, extended regimen oral contraceptive for the prevention of pregnancy. The submission was based on a clinical development program including results from Phase I, Phase II, and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette in the prevention of pregnancy. The clinical trials involved more than 3,000 female subjects. Quartette is a trade mark of USA-based Barr Pharmaceuticals, which Teva acquired for $7.46 billion in 2008.
Less disruptive unscheduled bleeding
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