Bayer HealthCare Pharmaceuticals, Inc. today announced the
FDA has approved a new oral contraceptive (OC), SAFYRALT (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 BeyazT (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.”