FDA批准Climara Pro（雌二醇/左炔诺孕酮透皮贴）首个仿制药，获批方为Zydus

FDA News Release
FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
- For Immediate Release:
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”)
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.
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