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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

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