The FDA has issued Wyeth an approvable letter for Lybrel, a low-dose, continuous, non-cyclic combination oral contraceptive, the company said.
In response to the letter, Wyeth said it 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.
Lybrel is an investigational low-dose combination of ethinyl estradiol and levonorgestrel for women who have no known contraindications for this method of contraception.
