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Seasonique

Generic name: levonorgestrel and ethinyl estradiol
Treatment for: Birth Control

Update: Seasonique Now FDA Approved - May 25, 2006

Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive

WOODCLIFF LAKE, N.J., August 18, 2005 -- Barr Pharmaceuticals, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has issued an Approvable letter for Duramed Pharmaceuticals, Inc.'s 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. To achieve final approval, the FDA has requested that the Company provide additional data to support Seasonique's unique regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen. Once approved, the Company intends to market Seasonique for the prevention of pregnancy in women who choose to take hormone products for contraception.

"We are pleased that the Agency has determined that our Seasonique extended-cycle oral contraceptive product is approvable for the prevention of pregnancy, which was the clinical endpoint of our original study," said Bruce L. Downey, Barr's Chairman and CEO. "We intend to seek a meeting with the Agency within the next 30 days to discuss our on-going studies of Seasonique and how they might satisfy FDA's request for additional information. We are confident that we can provide the information requested in the Agency's approvable letter."

The Company is committed to the extended-cycle oral contraceptive category it created with the launch of the Seasonale extended-cycle oral contraceptive in 2003. Over 1 million prescriptions have been written for Seasonale since launch. In addition to Seasonique, the Company's pipeline of extended-cycle oral contraceptive products also includes a NDA currently pending at the FDA for Seasonale Lo (levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg tablets) extended-cycle oral contraceptive.

Under 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 0.01 mg of ethinyl estradiol. The regimen is designed to reduce the number of withdrawal bleeding periods from monthly to four per year. The clinical data supporting the Seasonique NDA resulted from one large pivotal randomized, open-label, multi-center trial and one supportive randomized, open-label, multi-center 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. Patients were enrolled in the pivotal trial for the duration of 12 months (four (4) 91-day cycles). An extension study of the pivotal trial is currently ongoing.

Important Information About Oral Contraceptives

It is estimated that more than 16 million women currently take oral contraceptives in the United States. Oral contraceptives are not for every woman. Serious as well as minor side effects have been reported with the use of hormonal contraceptives. Serious risks include blood clots, stroke, and heart attack. Cigarette smoking increases the risk of serious cardiovascular side effects, especially in women over 35 years. Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Source: Barr Pharmaceuticals, Inc.

Posted: August 2005

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