The FDA has approved Schering AG's new low dose oral contraceptive, Yaz. The drug will be launched in the US in April 2006 by Schering's US affiliate, Berlex.
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Yaz has a dosing regimen of 24 days of active hormone pills and four days of placebo, reducing the typical monthly hormonal fluctuations compared to traditional oral contraceptives with regimens of 21 days of active pills and seven days of placebo.
“The Yaz approval is an important milestone for Schering. This significantly adds to the blockbuster potential of our Yasmin product family”, said Dr Hubertus Erlen, chairman of the executive board of Schering AG. “Yaz joins the most innovative oral contraceptive portfolio worldwide, and will certainly contribute to our near and long-term success.”
Like Yasmin, Yaz contains the innovative progestin drospirenone. Drospirenone exhibits antimineralocorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives.
Schering continues to pursue FDA approval of Yaz for the treatment of emotional and physical symptoms of premenstrual dysphoric disorder, which is a severe form of premenstrual symptoms (PMS), among women who desire contraception.