FDA Approves First Generic Version of Climara Pro: Zydus Once-Weekly Hormone Therapy Patch Cleared
The U.S. Food and Drug Administration (FDA) on October 19 approved Zydus Pharmaceuticals' estradiol/levonorgestrel transdermal system (0.045/0.015 mg per day, applied once weekly), the first generic version of the brand-name drug Climara Pro.
The patch is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause, such as hot flashes and night sweats, and for the prevention of postmenopausal osteoporosis. Climara Pro, made by Bayer and approved in 2003, had never had a generic version before. Each system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel and delivers the hormones continuously through the skin.
The approval comes amid rising demand for estradiol patches. In September, the FDA said it was working with six manufacturers, including Zydus, Bayer, Sandoz and Viatris, to increase the supply of estradiol patches; demand rose in part after the FDA's November 2025 action asking manufacturers to remove the long-standing boxed warnings from menopausal hormone therapy labeling.
FDA labeling also states that estrogen plus progestin therapy should use the lowest effective dose for the shortest duration consistent with treatment goals, and that when prescribed solely for the prevention of postmenopausal osteoporosis, it should be considered only for women at significant risk of osteoporosis.
Published by GSM · USA (original Chinese edition)
Photo: 一名女性正在贴敷透皮贴片（资料图）。British Columbia Institute of Technology 摄，CC BY 4.0 授权图片，经 Wikimedia Commons 发布／A woman applying a transdermal patch (file photo). Photo: British Columbia Institute of Technology, CC BY 4.0, via Wikimedia Commons
