Drugs and FDA
FDA approves first generic Climara Pro hormone therapy patch
The once-weekly generic patch is approved for postmenopausal women with an intact uterus to treat moderate to severe vasomotor symptoms and prevent osteoporosis.
The FDA approved Zydus Pharmaceuticals’ estradiol and levonorgestrel transdermal system, the first generic version of Climara Pro, according to the agency. The once-weekly patch is approved for women with an intact uterus to treat moderate to severe vasomotor symptoms and prevent postmenopausal osteoporosis. It delivers 0.045 mg of estradiol and 0.015 mg of levonorgestrel per day.
The FDA says the progestogen is included to reduce the risk of endometrial hyperplasia that can occur with estrogen use alone. The agency lists contraindications including unexplained genital bleeding, breast cancer or a history of it, blood clots, liver disease and certain clotting disorders. Common adverse reactions include application site reactions, vaginal bleeding, breast pain, headache and depression.
The FDA says the generic is therapeutically equivalent to Climara Pro and approved Zydus Pharmaceuticals (USA) Inc. to make it. The agency advises patients to contact the manufacturer for information about availability.
