Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the U.S. Food and Drug Administration (FDA) has approved the oral contraceptive Lybrel? (90 mcg levonorgestrel/20 mcg ethinyl estradiol) tablets for the prevention of pregnancy in women who elect to use oral contraceptives and who have no known contraindications for this method of contraception.
Lybrel is the first and only low dose combination contraceptive pill taken 365 days a year, without a placebo phase or pill-free interval. Available by prescription, Lybrel is expected to be in U.S. pharmacies in July 2007.
Lybrel is intended for women who are seeking contraception and who are interested in putting their menstrual cycle on hold. Lybrel provides a steady low dose of hormones so that over time women may become cycle-free. Women considering Lybrel should know that most subjects in the clinical studies experienced some breakthrough bleeding and spotting, especially during the first three to six months. In studies and analyses, Lybrel did not delay a return to fertility nor did it affect return to menses.
As part of a postmarketing commitment, Wyeth will conduct a study of thromboembolic events among women prescribed Lybrel compared to women prescribed cyclic oral contraceptives containing 20 mcg ethinyl estradiol.
?For those women seeking contraceptive options and who are interested in putting their period on hold,? says Ginger Constantine, M.D., Vice President, Women?s Health Care, Wyeth Pharmaceuticals, ?Lybrel may be an appropriate choice.?