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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