US FDA approves Bayer's Beyaz, a combination contraceptive with folate, and Allergan's Ozurdex

The US Food and Drug Administration on Friday approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg), from German drug major Bayer (BAY: DE).

Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body. A known association of low folate levels and neural tube defects (eg, spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate. Beyaz is based on Bayer’s approved contraceptive YAZ, which contains the same doses of estrogen and progestin, and is approved for:

• Prevention of pregnancy
• Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
• Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.