SeasoniqueTreatment for Contraception
Update: Seasonique Now FDA Approved - May 25, 2006
Barr Confirms that Additional Clinical Data Is Not Required for Approval of Duramed's Seasonique Extended-Cycle Oral Contraceptive
WOODCLIFF LAKE, N.J., March 17, 2006 -- Barr Pharmaceuticals, Inc. today was informed by the U.S. Food and Drug Administration (FDA) that additional clinical data will not be required to support the approval of 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. The Company said that it will continue to work with FDA to resolve outstanding issues including product labeling and post marketing commitments.
In August, the FDA issued an approvable letter that requested 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 appreciate the Agency's attention to this matter and are pleased that they have decided that no additional clinical data is required for the ultimate approval of our Seasonique extended-cycle oral contraceptive product," said Bruce L. Downey, Barr's Chairman and CEO. "We will continue to work closely with the Agency to resolve outstanding issues as quickly as possible, and provide the package, labeling and other information they have requested so that the review and approval of this application proceeds as quickly as possible."
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 1.6 million prescriptions have been written for Seasonale since launch. Seasonique will be the second product in a long line of internally developed research and development projects in the contraceptive category.
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. 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: March 2006
- FDA Approves Duramed's Seasonique Extended-Cycle Oral Contraceptive - May 27, 2006
- Barr Receives Approvable Letter for Duramed's Seasonique Extended-Cycle Oral Contraceptive - August 18, 2005
- Duramed's Seasonique NDA Accepted for Filing by FDA - December 22, 2004
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