FDA accepts Barr's Lo Seasonique NDA

US generics firm Barr Pharmaceuticals says that its subsidiary, Duramed Pharmaceuticals, has received Food and Drug Administration notification that its extended-cycle oral contraceptive Lo Seasonique (levonogestrel/ethinyl estradiol tablets 0.10mg/0.02mg and ethinyl estradiol tablets 0.01mg) has been accepted for review.

Under the Lo Seasonique regimen, women take active tablets combining 0.10mg levonogestrel and 0.02mg of ethinyl estradiol for 84 consecutive days, followed by seven days of ethinyl estradiol 0.01mg. The product is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.

Barr said that its New Drug Application submission included supportive data from an open-label clinical trial, completed last year, which examined Lo Seasonique over a 12-month period.