You are here
NDA for New Contraception With Uninterrupted Dosing Regimen Accepted for Filing
"This NDA is an important event in the evolution of oral contraceptives. No combination oral contraceptive is currently approved with this continuous, uninterrupted regimen," says Dr. Ginger Constantine, Vice President, Women's Health Care and Bone Repair, Wyeth Pharmaceuticals. "Wyeth developed this contraceptive so that women may have an additional option to manage their cycles. The studies to support this product are a reflection of our longtime commitment to innovation in women's health."
The NDA submission included data from two one-year Phase III clinical trials. These trials enrolled a total of 2,775 women and evaluated the safety and efficacy of the product for contraception. In addition, one of the secondary endpoints included was menses inhibition. In the clinical trials, the more commonly reported adverse events included headaches, vaginal bleeding and cramps.
Filing an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing does not indicate that approval has been or will be issued, nor does it represent an evaluation of the adequacy of the data submitted.
About Oral Contraceptives
Oral contraceptives are not for every woman. Most related side effects are not serious. Serious side effects occur infrequently. Serious risks of all 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 the oral contraceptives, specially women who have had a heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding and those who are or may become pregnant. Oral contraceptives do not protect against HIV infection (AIDS) or sexually transmitted diseases.
Source: Wyeth Pharmaceuticals