Barr Pharmaceuticals' subsidiary, Duramed Pharmaceuticals, Inc., has received notification that the US FDA had accepted for review its New Drug Application (NDA) for Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive.

The Company is seeking approval to manufacture and market Seasonique extended- cycle oral contraceptive for the prevention of pregnancy. The Prescription Drug User Fee Action (PDUFA) date for the Seasonique NDA is August 19, 2005.

"Seasonique represents our second entrant into the extended-cycle oral contraceptive product category we created with the launch of our Seasonale product last year. If ultimately approved by the FDA, it will join Seasonale in offering American women an additional, innovative option in birth control," said Dr. Carole S. Ben-Maimon, president and COO of Duramed Research. "While acceptance for filing of an NDA does not assure approval, we believe our clinical data indicates that the Seasonique extended-cycle oral contraceptive therapy prevents pregnancy and has a comparable safety profile to more traditional oral contraceptives," Dr. Carole added.

The clinical data supporting the Seasonique NDA resulted from one large pivotal randomized, open-label, multi-centre trial and one supportive randomized, open-label, multi-centre trial, both of which ended in April 2004. The trials involved approximately 2,500 female patients between the ages of 18-40 at 43 sites in the United States, the company release said.