Yaz cleared for acne by the FDA

Berlin, Germany-based Bayer Schering Pharma, the recently-established health care division of Bayer AG, says that the US Food and Drug Administration has granted its oral contraceptive Yaz (3mg drospirenone/20mcg ethinyl estradiol) approval as a treatment for moderate acne in women.

The firm explained that the FDA's decision is based on the findings of two multicenter trials of the drug that enrolled over 1,000 patients. The results revealed that use of Yaz brought about significant reductions in total lesion count, as well as lowering the level of inflammatory and non-inflammatory lesions. In addition, the company reported that the number of investigator ratings of "clear" and "almost clear" on the Static Global Assessment Scale was nearly four times higher in the drug-treated group than the placebo arm.

The company said that, with the approval, the drug becomes the only oral contraceptive licensed for three distinct indications, following its clearance as both a contraceptive and as a treatment for the physical symptoms of premenstrual dysphoric disorder last year (Marketletters passim). The firm added that the product will help strengthen its position in the field of female contraception.