U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels

Thu, 12/16/2010 - 4:36pm

WAYNE, N.J., Dec. 16, 2010 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets).  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 SAFYRAL or shortly after discontinuing it.  SAFYRAL provides the birth control YASMIN® (drospirenone 3 mg/ ethinyl estradiol 30 mcg) with 451 mcg levomefolate calcium, which is a B vitamin.

SAFYRAL is the second Bayer OC which contains folate.  In September, the FDA approved Beyaz™ (drospirenone 3 mg/ ethinyl estradiol 20 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium  451 mcg tablets), the first OC approved by the FDA to raise folate levels in women who choose an OC for birth control.

"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.  "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."

The Centers for Disease Control and Prevention, the U.S. Preventive Services Task Force, the March of Dimes and other leading health authorities recommend that all women of childbearing age supplement their diet with at least 400 mcg of folic acid daily.(1),(2),(3)  A well-established body of evidence supports folate supplementation as a means to reduce the incidence of neural tube defects  – rare birth defects of the brain and spinal cord.(2),(3),(4)  These rare birth defects happen in the first few weeks of p





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