Bayer has announced two new approvals for contraceptives that it got the rights to as part of its acquisition of fellow German firm Schering AG.
Firstly the company said that the Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Mirena, Bayer Schering Pharma's levonorgestrel-releasing intrauterine contraceptive system and a launch is planned for April.
“In Japan there has been a limited choice in convenient, reliable and reversible long-acting contraception,” claimed Phil Smits, head of women’s healthcare at the firm, who added that with the Mirena launch, “we will further strengthen our leading position on the Japanese market and grow our worldwide leadership in female contraception.”
The second bit of good news involves Berlex, a US affiliate of Bayer Schering Pharma, which revealed that the US Food and Drug Administration has approved a new indication for Yaz (drospirenone/ethinyl estradiol) to treat moderate acne vulgaris in women who desire an oral contraceptive for birth control.
Yaz received FDA approval as a contraceptive in March last year, and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder last October. Berlex chief executive Reinhard Franzen said this latest regulatory approval “underscores the culmination of years of research that confirms the promise of Yaz…in delivering benefits that are beyond reliable birth control."