The first generic version of Climara Pro, a weekly transdermal hormone therapy patch, was approved by the U.S. Food and Drug Administration (FDA) on Oct. 20.

The generic estradiol and levonorgestrel transdermal system is for women with an intact uterus in the treatment of moderate to severe vasomotor symptoms due to menopause and for prevention of postmenopausal osteoporosis. 

It differs from estrogen-only patches often used in menopause and is approved only for women with intact uterus, as the progestogen component is included to reduce the risk of endometrial hyperplasia that can occur with estrogen alone.

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

Climara Pro and its generic equivalent are contraindicated in patients with undiagnosed abnormal genital bleeding; breast cancer or a history of breast cancer; estrogen-dependent neoplasia; active deep vein thrombosis (DVT), pulmonary embolism (PE) or a history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema or hypersensitivity to estradiol and levonorgestrel; hepatic impairment or disease; and protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders.