FDA Approves Bayer’s Combination Drug Beyaz Based on Contraceptive Yaz

The Food and Drug Administration Sept. 24 approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body, FDA said. A known association of low folate levels and neural tube defects has resulted in recommendations that women of childbearing age supplement their diet with folate.

Beyaz, which is manufactured by Bayer HealthCare Pharmaceuticals Inc., is based on the approved product Yaz, FDA said. Yaz contains the same doses of estrogen and progestin. It ...