The FDA has approved the NDA for Seasonique (canadian levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg and ethinyl estradiol 0.01 mg) tablets (Barr Phar-maceuticals/Duramed) to prevent pregnancy. Seasonale, Barr’s earlier extended-cycle oral contraceptive, was launched in 2003 as a 91-day regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by seven days of placebo (inactive) tablets, thus offering the convenience of just four menstrual periods per year.
Seasonique provides continuous hormonal support in the form of a low dose of estrogen in place of seven placebo tablets taken during the month. Patients take the active tablets for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is also designed to reduce the number of withdrawal bleeding periods to four times per year.
Barr received an approvable letter for Seasonique in August 2005. In March 2006, the FDA determined that no additional clinical studies would be required to support the approval.