Please login to the form below

Not currently logged in
Email:
Password:

Bayer contraceptive approved

Bayer has received US Food and Drug Administration approval for its oral contraceptive formulated to reduce neural tube defects in pregnancies

Bayer HealthCare Pharmaceuticals has received US Food and Drug Administration (FDA) approval for its second oral contraceptive that is formulated with folate. This is in order to reduce neural tube defects in pregnancies that happen while women are taking the pill or shortly after they stop taking the pill.

The product, called Safyral, adds the B vitamin levomefolate calcium to Bayer's marketed oral contraceptive Yasmin. The 21/7 day regimen consists of 21 days of drospirenone 3 mg/ethinyl estradiol 30 mcg with the B vitamin, followed by seven days of the vitamin only.  

Safyral is expected to be available in mid-January.

The FDA approval is based on two clinical trials in which the most common side effects were headache/migraine, menstrual irregularities, nausea/vomiting and breast pain/tenderness, premenstrual syndrome, and abdominal pain/discomfort/tenderness.

The approval comes a few months after the FDA approved Beyaz, which combines levomefolate calcium with Yaz (drospirenone, ethinyl estradiol), and which was the first birth control pill cleared in the US to raise folate levels.

The new oral contraceptive products are being introduced by Bayer at a time when Yasmin and Yaz, which are identical to each other except for their dosing regimens, are beginning to face generic competition in the US. Barr Pharmaceuticals launched a lower-cost generic version of Yasmin in 2008 and plans a generic version of Yaz for 2011.

The Yasmin/Yaz branded products, which were acquired as part of Bayer's 2006 takeover of Schering, have been top-sellers for the company. Last year, Yaz sales rose about 5 per cent to $1.74bn.

20th December 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Atlantis Healthcare

Atlantis Healthcare is a global leader in optimising patient self-management. Established in 1996, we design, develop and implement scalable solutions...

Latest intelligence

Erik
A quest for innovative solutions
UCB looks to the future through a PRISM...
Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...
Deal Watch January 2018
...

Infographics