---
title: "FDA Approves First Generic Once-Weekly Estradiol–Levonorgestrel Patch for Women"
id: "fda-news-releases-1-fda-approves-once-weekly-generic-hormone-therapy-patch-for-women"
canonical_url: "https://medichelpline.com/clinical-feed/fda-news-releases-1-fda-approves-once-weekly-generic-hormone-therapy-patch-for-women"
content_type: "clinical_feed_article"
specialty: "Endocrinology"
source_name: "FDA News Releases"
source_url: "http://www.fda.gov/news-events/press-announcements/fda-approves-once-weekly-generic-hormone-therapy-patch-women"
published_at: "2026-10-20T15:57:36.000Z"
evidence_level: "Agency Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA Approves First Generic Once-Weekly Estradiol–Levonorgestrel Patch for Women
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/fda-news-releases-1-fda-approves-once-weekly-generic-hormone-therapy-patch-for-women
- **Specialty:** [Endocrinology](https://medichelpline.com/clinical-feed/endocrinology.md)
- **Primary Source:** FDA News Releases
- **Source URL:** [Original Journal Publication](http://www.fda.gov/news-events/press-announcements/fda-approves-once-weekly-generic-hormone-therapy-patch-women)
- **Published At:** 2026-10-20T15:57:36.000Z
- **Evidence Rating:** Agency Feed
## Executive GIST (TL;DR)
- The FDA approved the first generic version of **Climara Pro** (an **estradiol and levonorgestrel transdermal system**) on October 20, 2026. - The product delivers estradiol 0.045 mg per day and levonorgestrel 0.015 mg per day and is applied once weekly, according to the agency announcement. - Investigators reported the generic is therapeutically equivalent to the reference listed drug, Climara Pro; the approval was granted for women with an intact uterus. - The indicated uses are treatment of moderate to severe **vasomotor symptoms** due to menopause and prevention of **postmenopausal osteoporosis**. - The patch combines estrogen and progestogen in one system; the progestogen component is included to reduce endometrial hyperplasia risk associated with estrogen-only therapy. - The FDA listed multiple contraindications: undiagnosed abnormal genital bleeding; breast cancer or history thereof; estrogen-dependent neoplasia; active or prior DVT/PE or arterial thromboembolic disease; known anaphylaxis/angioedema to the active ingredients; hepatic impairment; and thrombophilic disorders. - The most common adverse reactions (≥5%) included application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome. - The agency named Zydus Pharmaceuticals (USA) Inc. as the approved manufacturer and noted Climara Pro is a Bayer trademark; readers were advised to contact the manufacturer about product availability. - The release linked this approval to FDA efforts to increase access to affordable medicines and to the Drug Competition Action Plan; the source did not report specific availability timing, pricing, or comparative clinical trial data versus the reference product.
## Clinical Analysis & Structured Key Points
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[Home](https://www.fda.gov/) 2. [News & Events](https://www.fda.gov/news-events) 3. [FDA Newsroom](https://www.fda.gov/news-events/fda-newsroom) 4. [Press Announcements](https://www.fda.gov/news-events/fda-newsroom/press-announcements) 5. FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women 1. [ Press Announcements ](https://www.fda.gov/news-events/fda-newsroom/press-announcements "Press Announcements") [In this section](https://www.fda.gov/news-events/press-announcements/fda-approves-once-weekly-generic-hormone-therapy-patch-women#section-nav) * [ Press Announcements ](https://www.fda.gov/news-events/fda-newsroom/press-announcements "Press Announcements") FDA News Release # FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women [ More Press Announcements](https://www.fda.gov/news-events/newsroom/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](https://www.fda.gov/about-fda/what-we-do/fdas-public-health-pillars "FDA's Public Health Pillars"): 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](https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan "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. 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