美国食品药品监督管理局批准用于女性的每周一次激素疗法仿制药贴片
正文 · 中文译文
FDA新闻稿 FDA批准每周使用一次的女性仿制药激素治疗贴片 更多新闻公告 立即发布： 2026年10月20日 美国食品药品监督管理局（FDA）昨日批准了Climara Pro（雌二醇和左炔诺孕酮透皮系统，每日0.045 mg/0.015 mg）的首个仿制药，这是一种适用于子宫完整的女性、每周使用一次的透皮激素治疗贴片。该批准与FDA的公共卫生支柱目标一致：增加可负担药物和医疗产品的可及性。 “更年期是女性普遍经历的过程，且可能极大地影响个人的生活质量。此次批准使有效治疗更加可及，”FDA代理局长Kyle Diamantas法学博士表示。“此类批准反映了FDA持续致力于扩大美国患者获得安全、可负担、高质量药物的途径。” 仿制雌二醇和左炔诺孕酮透皮系统与Climara Pro具有治疗等效性，后者适用于子宫完整的女性，用于： 治疗更年期引起的中度至重度血管舒缩症状 预防绝经后骨质疏松症 Climara Pro及仿制药雌二醇和左炔诺孕酮透皮系统在单个贴片中同时含有雌激素和孕激素；这不同于绝经治疗中常用的单纯雌激素贴片。Climara Pro及仿制药雌二醇和左炔诺孕酮透皮系统专门批准用于子宫完整的女性，因为所含孕激素成分旨在降低单独使用雌激素可能导致的子宫内膜增生风险。 “每周一次给药可以真正改变患者管理自身治疗的方式，”FDA药物评价与研究中心主任Michael Davis医学博士、哲学博士表示。“贴片为每日口服药物提供了一种便捷的替代方案，这可能有助于患者坚持治疗方案。” Climara Pro及仿制药雌二醇和左炔诺孕酮透皮系统禁止用于以下患者：未明确诊断的异常生殖道出血；乳腺癌或有乳腺癌病史；雌激素依赖性肿瘤；活动性深静脉血栓形成（DVT）、肺栓塞（PE）或有这些病史；活动性动脉血栓栓塞性疾病或有这些病史；已知对雌二醇和左炔诺孕酮有过敏反应或血管性水肿或过敏；肝功能损害或肝脏疾病；以及蛋白C、蛋白S或抗凝血酶缺乏，或其他血栓形成倾向性疾病。 最常见的不良反应（大于或等于5%）为：给药部位反应、阴道出血、乳房疼痛、上呼吸道感染、背痛、抑郁、疼痛、头痛和流感样综合征。 在美国，处方药中每十张就有九张是仿制药。提高仿制药的可及性有助于在市场中形成竞争，从而使治疗更加经济实惠，并让更多患者获得医疗服务。了解更多关于FDA药品竞争行动计划的信息。 Climara Pro是拜耳公司的注册商标。FDA批准了Zydus Pharmaceuticals (USA) Inc.的雌二醇和左炔诺孕酮透皮给药系统。有关该药品的可及性信息，请联系制造商。 相关信息 仿制药 经治疗等效性评价批准的药品（俗称“橙皮书”） 媒体： FDA征求意见 202-690-6343 消费者： 888-INFO-FDA FDA是美国卫生与公众服务部下属机构，通过确保人用和兽用药品、疫苗及其他人类用生物制品和医疗器械的安全性、有效性和可靠性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、发射辐射的电子产品的安全与保障，并负责监管烟草产品。 ### 内容更新日期： 2026年10月20日 监管产品 药品 关注FDA 在X上关注@US_FDA 在Facebook上关注FDA 在X上关注@FDAMedia
正文 · 英文原文
FDA News Release FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women More Press Announcements For Immediate Release: October 20, 2026 The U.S. Food and Drug Administration yesterday approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal hormone therapy patch for women with an intact uterus applied once a week. The approval aligns with FDA’s Public Health Pillar: Increasing Access to Affordable Medicines & Medical Products. “Menopause is a universal experience for women, and it can greatly affect a person’s quality of life. This approval makes effective treatment more accessible,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Approvals like this reflect FDA’s ongoing commitment to expanding American patient access to safe, affordable, high-quality medications.” The generic estradiol and levonorgestrel transdermal system is therapeutically equivalent to Climara Pro, which is indicated for use in women with an intact uterus for: Treatment of moderate to severe vasomotor symptoms due to menopause Prevention of postmenopausal osteoporosis Climara Pro and the generic estradiol and levonorgestrel transdermal system contain both estrogen and progestogen in a single patch; this differs from estrogen-only patches commonly used in menopause treatment. Climara Pro and the generic estradiol and levonorgestrel transdermal system are specifically approved for women with an intact uterus, as the progestogen component is included to reduce the risk of endometrial hyperplasia that can occur with estrogen use 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 the generic estradiol and levonorgestrel transdermal system 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. The most common adverse reactions (greater than or equal to 5%) are: application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome. In the U.S., nine out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. Learn more about the FDA Drug Competition Action Plan. Climara Pro is a registered trademark of Bayer. The FDA approved Zydus Pharmaceuticals (USA) Inc.’s Estradiol and Levonorgestrel Transdermal System. Please contact the manufacturer for information about the medicine’s availability. Related Information Generic Drugs Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. ### Content current as of: 10/20/2026 Regulated Product(s) Drugs Follow FDA Follow @US_FDA on X Follow FDA on Facebook Follow @FDAMedia on X