Barr Pharmaceuticals' subsidiary Duramed Pharmaceuticals, Inc., said US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Lo Seasonique extended-cycle oral contraceptive for review.
The company is seeking approval to manufacture and market the Lo Seasonique, (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg), the first lower dose, extended-cycle oral contraceptive for the prevention of pregnancy. The prescription drug user fee action (PDUFA) date for the Lo Seasonique NDA is October 24, 2008.
The clinical data supporting the Lo Seasonique NDA resulted from one large pivotal multi-cantered, open label clinical trial which concluded in June 2007. The clinical trial involved over 2,200 female subjects between the ages of 18 and 40 at 56 sites throughout the United States. Subjects were enrolled in the clinical trial for a duration of 12 months.
Under the Lo Seasonique extended-cycle regimen, women take active tablets of 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries.