Key Marketed Proprietary Products > SEASONIQUE®

SEASONIQUE® is an FDA-approved, extended-cycle oral contraceptive for the prevention of pregnancy. SEASONIQUE® is an extended-cycle oral contraceptives in a category the Company established with the launch of the SEASONALE® extended-cycle oral contraceptive in 2003.

The majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days of active ingredient followed by a seven-day placebo interval. By contrast, with the SEASONIQUE® extended-cycle regimen, women take active tablets of 0.15 mg levonorgestrel/0.03 mg of ethinyl estradiol for 84 consecutive days, followed by seven days of low-dose estrogen (0.01 mg of ethinyl estradiol). The regimen is designed to reduce the number of withdrawal bleeding periods from monthly to four per year, while providing continuous hormonal support in the form of a low-dose of estrogen in place of the seven placebo pills.

The Duramed Women's Healthcare and Institutional Sales Forces promote SEASONIQUE® to approximately 40,000 physicians and other healthcare providers in the United States. Duramed has also initiated a fully integrated marketing campaign, aimed at healthcare providers and patients, which includes professional education materials, published data from our clinical studies demonstrating the safety and efficacy of the extended-cycle SEASONIQUE® regimen, and product sampling kits that contain extensive information for patients. Duramed reinforces detailing activities with medical journal advertising and a direct-to-consumer advertising campaign, including television, print and Internet-based advertising.

Important Safety Information

While you get four periods a year, you're also more likely to have bleeding or spotting between periods. This can be slight to a flow like a regular period and should decrease over time.

Like other birth control pills, SEASONIQUE® has serious risks, which can be life threatening. They include blood clots, stroke, and heart attack. Smoking increases these risks, especially if you are over 35, so Pill users should not smoke.

Some women should not take the Pill, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who could be pregnant. No Pill protects against HIV and other sexually transmitted diseases (STDs).

Please see complete prescribing information at www.SEASONIQUE.com.

Click HERE to download Patient Information Brochure.

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