Berlex, the US affiliate of German drugmaker Schering AG said yesterday that its oral contraceptive YAZ had become the first and only product of its type to be approved for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder in the USA.
YAZ (drospirenone/ethinyl estradiol), which received FDA approval for the prevention of pregnancy in March 2006, is the fastest-growing oral contraceptive brand in the USA, according to the company.
The new label states that YAZ is effective in the treatment of PDD in women who choose to use an OC as their method of contraception, said Berlex.
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.
PMDD is also linked to higher health care costs related to more frequent visits to health care providers, decreased work productivity and absenteeism, said Berlex.
Schering, which has is in the final throes of a merger with fellow German company Bayer, has predicted that YAZ' sales could reach 200 million euros ($247m) at peak.