Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer HealthCare Pharmaceuticals’ new oral contraceptive (OC), Beyaz (drospirenone / ethinyl estradiol / levomefolate calcium tablets and levomefolate calcium tablets), has received approval from the US Food and Drug Administration (FDA).
Subscribe to our email newsletter
Bayer claimed that Beyaz is the first OC approved to raise folate levels, in women who choose an OC for birth control, for the purpose of reducing the risk of a neural tube defect (NTD) in a pregnancy conceived while taking Beyaz or shortly after discontinuing it.
Beyaz is known to combine the hormone ingredients in the birth control pill YAZ (drospirenone 3mg/ ethinyl estradiol 20mcg) with 451mcg levomefolate calcium, which is a B vitamin.
Bayer HealthCare Pharmaceuticals Women’s HealthCare Marketing vice president Leslie North said that Beyaz enables women who choose an OC as their method of contraception to also raise their folate levels during continued use.
Beyaz received FDA approval based on the results from a multicenter, randomised, double-blind, parallel group study conducted in a US population with folate fortified food which evaluated the effect of Beyaz on red blood cell (RBC) folate and plasma folate levels compared to YAZ during 24 weeks of treatment.