Beyaz oral contraceptive that raises folate levels approved

The FDA has approved Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets, from Bayer HealthCare), an oral contraceptive that raises folate levels. This approval was based on data from a multicenter, randomized, double-blind, parallel group, 24-week study in 379 healthy women that evaluated the effects of Beyaz on red blood cell (RBC) folate and plasma folate levels compared to Yaz (drospirenone/ethinyl estradiol, from Bayer HealthCare). Mean changes from baseline at week 24 were higher for women who took Beyaz as compared to women who took Yaz (p<0.0001), for RBC folate (420 +/-347 nmol/L vs. 34.3 +/- 171 nmol/L, respectively) and plasma folate (15.8 +/- 20.4 nmol/L vs. -2.2 +/- 14.6 nmol/L, respectively) levels.

Beyaz is approved for the prevention of pregnancy, treatment of symptoms of premenstrual dysphoric disorder (PMDD), treatment of moderate acne for women at ≥14 years of age who have started having menstrual periods, and to raise folate levels in women who choose oral contraceptives for birth control for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Beyaz is a 24/4 day regimen consisting of 24 days of drospirenone 3mg/ethinyl estradiol 20mcg/levomefolate calcium (Metafolin) 451mcg followed by four days of Metafolin only. Beyaz is expected to be available in October 2010.

For more information call (877) 745-5855 or visit www.beyaz.com.