The FDA has approved the first generic of the once-weekly estradiol and levonorgestrel transdermal system, originally sold as Climara Pro. The patch is cleared for postmenopausal women with an intact uterus to treat moderate to severe hot flashes and to prevent osteoporosis. The approval follows recent endorsements of menopausal hormone therapy from the American College of Obstetricians and Gynecologists and the American College of Physicians.
The patch delivers 0.045 mg of estradiol and 0.015 mg of levonorgestrel per day. Levonorgestrel, a progestogen, is included to reduce the risk of endometrial hyperplasia that can occur with estrogen alone. The FDA noted that once-weekly dosing may help patients adhere to treatment compared with daily oral medications.
The prescribing information lists contraindications including undiagnosed abnormal genital bleeding, known or suspected breast cancer, active thromboembolic disease, and liver impairment. Common adverse events reported in at least 5% of users include application site reactions, vaginal bleeding, upper respiratory infection, breast pain, headache, and depression. A boxed warning remains in place regarding risks of cardiovascular disorders, probable dementia, and breast and endometrial cancer, based on Women's Health Initiative findings—though the FDA recently said it plans to drop these warnings from many menopausal hormone therapy products.