The Food and Drug Administration has approved the first generic version of Climara Pro, an estradiol and levonorgestrel transdermal system made by Zydus Pharmaceuticals (USA) Inc. and applied once a week. The patch, at 0.045 milligrams per day of estradiol and 0.015 milligrams per day of levonorgestrel, is therapeutically equivalent to Bayer’s brand product and is approved for women with an intact uterus, for treating moderate to severe vasomotor symptoms of menopause and for preventing postmenopausal osteoporosis.
The combined formulation is the point of the product: the progestogen component is included to reduce the risk of endometrial hyperplasia that estrogen alone can cause in women who still have a uterus, a risk estrogen only patches do not address in the same way. Acting FDA Commissioner Kyle Diamantas said the approval makes effective treatment more accessible, and Michael Davis, director of the Center for Drug Evaluation and Research, said once weekly dosing may help patients stay on track compared with daily oral medication. The agency framed the approval under its push to increase access to affordable medicines, noting that nine in ten United States prescriptions are already filled with generics.