FDA actions in brief

FDA approved 3 mg drospirenone/20 mcg ethinyl estradiol (Yaz, Berlex) for the treatment of moderate acne vulgaris in women who desire an oral contraceptive for birth control. This agent was previously approved for oral contraception and for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder in women who desire an oral contraceptive.

Azacitidine (Vidaza, Pharmion) was approved for intravenous injection for the treatment of patients with myelodysplastic syndromes, including the subtypes of refractory anemia or refractory anemia with ringed sideroblasts if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; and chronic myelomonocytic leukemia. This agent is already approved for subcutaneous injection for these same indications.

Clobetasol foam, 0.05% (Olux-E, Stiefel) was approved for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged ≥12 years.

FDA approved new dosing recommendations for sirolimus (Rapamune, Wyeth) for the treatment of renal transplant recipients at high immunologic risk. It is recommended that sirolimus be used in combination with cyclosporine and corticosteroids for the first year after transplantation. The new recommendations also allow for the use of sirolimus in combination with antibody induction therapy in this patient population.