Barr Pharmaceuticals, Inc. has announced that the FDA has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for LoSEASONIQUE(R) (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. LoSEASONIQUE(R) is the first lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.
Under the LoSEASONIQUE(R) extended-cycle regimen, women take combination tablets containing 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol daily for 84 consecutive days, followed 0.01 mg ethinyl estradiol tablets for seven days. 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.
LoSEASONIQUE(R) will be shipped to trade customers and available by prescription to women in the first quarter of 2009. Duramed will initiate promotion to healthcare providers in early 2009 using its sales force and other marketing initiatives.
"As a leader in women's health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers," said Fred Wilkinson, Duramed's Chief Executive Officer. "We're pleased that the FDA has approved LoSEASONIQUE(R) as a safe, effective new birth control option for U.S. women."