FDA APPROVES SEASONIQUE NDA

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The FDA has approved Duramed Pharmaceuticals' 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 for the prevention of pregnancy.

Seasonique is part of the company's extended-cycle oral contraceptives category, which was created with the launch of the Seasonale extended-cycle oral contraceptive in 2003.