FDA Approves LoSeasonique
FDA Approves Duramed's LoSeasonique Oral Contraceptive
MONTVALE, N.J., October 27, 2008 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for LoSeasonique (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. LoSeasonique is the first lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.
Under the LoSeasonique extended-cycle regimen, women take combination tablets containing 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol daily for 84 consecutive days, followed 0.01 mg ethinyl estradiol tablets for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year. By contrast, the majority of oral contraceptive products currently available in the United States are based on a regimen of 21 treatment days, followed by seven days of placebo.
LoSeasonique will be shipped to trade customers and available by prescription to women in the first quarter of 2009. Duramed will initiate promotion to healthcare providers in early 2009 using its sales force and other marketing initiatives.
"As a leader in women's health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers," said Fred Wilkinson, Duramed's Chief Executive Officer. "We're pleased that the FDA has approved LoSeasonique as a safe, effective new birth control option for U.S. women."
LoSeasonique is a lower dose extended cycle oral contraceptive indicated for the prevention of pregnancy. The clinical data supporting the LoSeasonique NDA resulted from a 12-month, multi-centered, open label clinical trial that concluded in June 2007. The clinical trial involved over 2,100 female subjects between the ages of 18 and 41 at 56 sites throughout the United States, and subjects completed an equivalent of nearly 21,000 28-day cycles of exposure.
The most common adverse events in the clinical trial were headache, irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or vomiting, and back pain.
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.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 26 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S. For more information, visit www.barrlabs.com.
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Posted: October 2008
- Duramed's Lo Seasonique NDA Accepted for Filing by FDA - February 25, 2008