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Extended-Cycle Oral Contraceptive Approved by FDA
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."
LoSEASONIQUE(R) is a lower dose extended cycle oral contraceptive indicated for the prevention of pregnancy. The clinical data supporting the LoSEASONIQUE(R) NDA resulted from a 12-month, multi-centered, open label clinical trial that concluded in June 2007. The clinical trial involved over 2,100 female subjects between the ages of 18 and 41 at 56 sites throughout the United States, and subjects completed an equivalent of nearly 21,000 28-day cycles of exposure.
The most common adverse events in the clinical trial were headache, irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or vomiting, and back pain.
Source: Barr Pharmaceuticals