Lybrel

levonorgestrel and ethinyl estradiol

Wyeth Receives Approvable Letter From the FDA for Lybrel

MADISON, N.J., June 28, 2006 -- Wyeth announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Lybrel (90 microgram levonorgestrel/20 microgram ethinyl estradiol tablets), a low dose, continuous, non-cyclic combination oral contraceptive. In response to the approvable letter, Wyeth will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data. The agency also indicated that it plans to convene a public meeting of contraceptive experts this year to discuss the clinical aspects of Lybrel. The anticipated topics include a review of the U.S. Pearl Index [a calculation of the pregnancy rates among study participants], bleeding patterns, and the discontinuation rate among women in the study.

"Wyeth is confident that we can address the questions raised by the FDA, and we expect to move toward the launch of Lybrel," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.

About Lybrel

Wyeth is seeking market approval for Lybrel, an investigational low dose combination oral contraceptive for the prevention of pregnancy in women who elect to use oral contraception and who have no known contraindications for this method of contraception. If approved, this investigational product will contain a low daily dose of ethinyl estradiol and levonorgestrel, a well- studied combination. It is expected to be the only combination oral contraceptive approved with this regimen designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval.

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 oral contraceptives, especially 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

Related Articles:

FDA Approves Lybrel, First Low Dose Combination Oral Contraceptive Offering Women the Opportunity to Be Period-Free Over Time - May 23, 2007

Wyeth's New Drug Application for New Oral Contraceptive With Uninterrupted Dosing Regimen Accepted for Filing at FDA - July 27, 2005

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