FDAnews Drug Daily Bulletin

The FDA will review the new drug application (NDA) for Barr’s Lo Seasonique extended-cycle contraceptive with an expected action date of Oct. 24.

If approved, Barr subsidiary Duramed’s Lo Seasonique  (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) would be the first lower-dose, extended-cycle oral contraceptive, Barr said.

The data supporting the NDA come from a multicentered, open-label trial that ended last June. The trial involved more than 2,200 female subjects between the ages of 18–40 at 56 sites throughout the U.S. Subjects were enrolled for a period of 12 months.

Under the Lo Seasonique extended-cycle regimen, women take 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.