FDA批准首个Climara Pro仿制药：Zydus每周一次激素贴片获批
美国食品药品监管局（FDA）10月19日批准 Zydus Pharmaceuticals 的雌二醇/左炔诺孕酮透皮系统（0.045/0.015 毫克/日、每周贴敷一次），这是原研药 Climara Pro 的首个仿制药版本。
该贴片的适应症为治疗绝经引起的中重度血管舒缩症状（如潮热、盗汗），以及预防绝经后骨质疏松。Climara Pro 由 Bayer 生产、2003年获批上市，此前一直没有仿制药版本；新获批的仿制贴片每贴含4.4毫克雌二醇与1.39毫克左炔诺孕酮，贴于皮肤后持续释放药物。
此次批准正值雌二醇贴片需求上升之际。FDA 今年9月表示，正与包括 Zydus、Bayer、Sandoz、Viatris 在内的六家生产商合作增加雌二醇贴片供应；需求上升部分源于 FDA 在2025年11月要求生产商修改绝经激素治疗产品标签、移除长期存在的「黑框警告」。
FDA 标签同时载明，雌激素与孕激素联合治疗应使用与治疗目标一致的最低有效剂量与最短疗程；仅为预防绝经后骨质疏松而处方时，应只考虑用于骨质疏松风险显著的女性。
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.
发布：GSM·美国（发布链接）
图片来源：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
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