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Schering's Yaz gets FDA nod for premenstrual tension
Berlin | Saturday, October 7, 2006, 08:00 Hrs  [IST]

Schering AG, Germany, announced that the US Food and Drug Administration (FDA) has approved YAZ (3 mg drospirenone/20 mcg ethinyl estradiol, in a 24-day active pill regimen) as the first and only oral contraceptive that is also clinically effective in treating the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD), for women who choose to use an oral contraceptive as their method of contraception.

PMDD is a condition in which women's emotional and physical premenstrual symptoms are disruptive enough to significantly impact relationships, social activities and work productivity. Symptoms of PMDD include mood swings, irritability, headaches, feeling anxious, bloating and food cravings. The symptoms regularly occur seven to 10 days before menstruation begins, and resolve within a few days of the onset of menses. While the symptoms of PMDD and premenstrual syndrome (PMS) are the same, women with PMDD experience five or more symptoms, which are more severe. PMDD is also linked to higher healthcare costs related to more frequent visits to healthcare providers, decreased work productivity and absenteeism.

"We are absolutely delighted with this approval as YAZ will strengthen our worldwide leading market position in the field of female contraception," said Philip Smits, MD, Head of Gynaecology and Andrology at Schering AG.

"Women have repeatedly told us they wanted relief from menstrual symptoms in addition to reliable, safe birth control. Because our progestin, drospirenone, has unique properties, we believed it had the potential to offer this relief. This potential was realised in clinical studies that showed YAZ was significantly superior to placebo across all symptoms of PMDD."

YAZ is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. YAZ, which has been available in the US since April 2006 as an oral contraceptive, is the fastest growing oral contraceptive brand in the US.

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