US FDA approves Bayer oral contraceptive Safyral that also raises folate levels

The US Food and Drug Administration has approved German dug major Bayer’s (BAY: DE) new oral contraceptive Safyral (drospirenone/ ethinyl estradiol/levomefolate calcium and levomefolate calcium), making this the second folate-containing OC that the FDA has approved recently, having cleared the Beyaz (an estrogen/progesterone combination with levomefolate) brand (The Pharma Letter September 26).

In women who choose an OC for birth control, Safyral raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking the product or shortly after discontinuing it. Safyral provides the birth control Yasmin (drospirenone/ethinyl estradiol) with 451mcg levomefolate calcium, which is a B vitamin.

"With the FDA approval of Safyral, Bayer now offers two oral contraceptives that contain folate," said Leslie North, vice president of marketing, Women's HealthCare, Bayer HealthCare Pharmaceuticals in the USA, adding: "Safyral and Beyaz are part of Bayer's growing women's health franchise, and these new products reinforce our commitment to providing women various contraceptive options."