FDA nod for Schering's new low dose oral contraceptive YAZ with 24-day regimen
The US Food and Drug Administration has approved the new low dose, monophasic oral contraceptive YAZ (3mg drospirenone/20 mcg ethinyl estradiol) of Schering AG, Germany. It is the first pill with the innovative progestin drospirenone, and a low dose of ethinyl estradiol in a new dosing regimen of 24 days of active hormone pills and four days of placebo.
YAZ will be launched in the US in April 2006 by Berlex, Inc., a US affiliate of Schering.
"The YAZ approval is an important milestone for Schering. This significantly adds to the blockbuster potential of our Yasmin product family", Dr. Hubertus Erlen, Chairman of the Executive Board of Schering AG said adding, "YAZ joins the most innovative oral contraceptive portfolio worldwide, and will certainly contribute to our near and long-term success."
Phil Smits, Head of Gynecology & Andrology at Schering AG said, "With YAZ, we offer women an innovative oral contraceptive that combines the unique advantages of drospirenone with a novel 24-day regimen. We will file YAZ in Europe very soon."
According to the company, the YAZ regimen reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with regimens of 21 days of active pills and seven days of placebo.
Schering continues to pursue FDA approval of YAZ for the treatment of emotional and physical symptoms of premenstrual dysphoric disorder (PMDD), which is a severe form of premenstrual symptoms (PMS), among women who desire contraception.
Like Yasmin, the number one brand birth control pill worldwide, YAZ contains the innovative progestin drospirenone. Drospirenone exhibits antimineralocorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives.