Barr Laboratories Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for its Seasonale extended regimen oral contraceptive.
The Company is seeking approval to manufacture and market Seasonale extended regimen oral contraceptive for the prevention of pregnancy. This represents the first NDA filing by the Company.
The clinical data supporting the NDA resulted from a randomized four-arm, open-label, multi-center trial that ended in March 2002. The trial involved approximately 1,400 female patients between the ages of 18-40 at 47 sites in the United States. An extension of this trial is ongoing.
Seasonale extended regimen oral contraceptive is an innovative patent-protected oral contraceptive product being developed through an agreement with Eastern Virginia Medical School (EVMS). Under the Seasonale extended regimen, women take active tablets for up to 84 consecutive days, followed by a seven day placebo interval. 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.
It is estimated that more 16 million women currently take oral contraceptives in the United States. Oral contraceptives are not for every woman. Serious risks associated with birth control pills that can be life threatening include blood clots, stroke and heart attack. These risks are increased in women who smoke cigarettes, especially women over 35. Women who use oral contraceptives should not smoke. Some women should not use birth control pills, including women who have had a heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding, and those who are or may be pregnant. Birth control pills do not protect against HIV infection (AIDS) or other sexually transmitted diseases.