FDA authorizes Bayer contraceptive for new indication

The approval makes Yaz the first and only oral contraceptive approved by the FDA for three distinct indications. Yaz has received approval as an oral contraceptive and as a treatment for the emotional and physical symptoms of premenstrual dysphoric disorder in women who desire an oral contraceptive.

“This latest regulatory approval underscores the culmination of years of research that confirms the promise of Yaz and the distinctness of our innovative progestin, drospirenone, in delivering benefits that are beyond reliable birth control,” said Reinhard Franzen, president and CEO of Berlex Laboratories.

According to Berlex, unlike other progestins, drospirenone has unique mild diuretic effect and antiandrogenic properties.

“The antiandrogenic property of drospirenone means that it blocks the male sex hormones that can cause acne,” said Ian Thorneycroft, professor of obstetrics and gynecology at the University of South Alabama.

Clinical trials showed that treatment with Yaz resulted in significant reductions in total, inflammatory and non inflammatory acne lesion counts. Further, investigator ratings of “clear” and “almost clear” skin were nearly four times greater in the Yaz treatment group than in the placebo group.