LoSEASONIQUE(R) is a lower dose extended cycle oral contraceptive indicated for the prevention of pregnancy. The clinical data supporting the LoSEASONIQUE(R) 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.
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.
About Barr Pharmaceuticals, Inc.
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 http://www.barrla
|SOURCE Barr Pharmaceuticals, Inc.|
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