Generic of Combination Hormone Therapy Patch Approved for Women

The FDA on Monday approved the first generic of the once-weekly estradiol and levonorgestrel transdermal system (Climara Pro) to treat moderate to severe vasomotor symptoms and prevent osteoporosis in women.

The patch is indicated for postmenopausal women with an intact uterus and follows recent endorsements from the American College of Obstetricians and Gynecologists and the American College of Physicians for menopausal symptoms.

“Once-weekly dosing can make a real difference in how patients manage their care,” said Michael Davis, MD, PhD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “A patch offers a convenient alternative to daily oral medications, which may help patients stay on track with their treatment.”

The patch delivers daily dosages of 0.045 mg of estradiol and 0.015 mg of levonorgestrel, a progestogen “included to reduce the risk of endometrial hyperplasia that can occur with estrogen use alone,” the agency noted.

The transdermal system is contraindicated in patients with undiagnosed abnormal genital bleeding, known or suspected breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, pulmonary embolism, active arterial thromboembolic disease, liver impairment, or known thrombophilic disorders (such as protein C, protein S, or antithrombin deficiency).

The most common adverse events reported (5% or more) with the once-weekly estradiol and levonorgestrel patch include application site reactions; vaginal bleeding; upper respiratory infection; breast, back, or general pain; depression; headache; and flu-like syndrome.

Based on findings from the Women’s Health Initiative, the prescribing information also carries a boxed warning regarding risks for cardiovascular disorders, probable dementia, breast cancer, and endometrial cancer, though the FDA recently announced plans to drop these boxed warnings from a number of hormone therapy products for menopausal symptoms.