Berlex Yaz gains acne claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Berlex's oral contraceptive Yaz (drospirenone/ethinyl estradiol) clears FDA Jan. 26 for the treatment of moderate acne vulgaris in women who desire an oral contraceptive for birth control. Based on two six-month trials in more than 1,000 patients, the oral contraceptive showed significant reduction in inflammatory and noninflammatory lesion counts. The approval marks the third indication for Yaz, which is also indicated for treatment of emotional and physical symptoms of premenstrual dysphoric disorder (1Pharmaceutical Approvals Monthly October 2006, p. 5)...