Barr’s subsidiary Duramed wins FDA approval for oral contraceptive

LoSeasonique is the first lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy, said Barr.

Under the LoSeasonique extended-cycle regimen, women take combination tablets containing 0.10mg levonorgestrel/0.02mg of ethinyl estradiol daily for 84 consecutive days, followed by 0.01mg 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 US are based on a regimen of 21 treatment days, followed by seven days of placebo, according to Barr.

LoSeasonique 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.

Fred Wilkinson, CEO of Duramed, said: “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. We’re pleased that the FDA has approved LoSeasonique as a safe, effective new birth control option for US women.”