Bayer HealthCare Pharmaceuticals, Inc. 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.”
Date: December 16, 2010
Source: Bayer HealthCare Pharmaceuticals, Inc.
Filed Under: Drug Discovery