The US Food and Drug Administration (FDA) has approved the first generic version of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg/day and 0.015 mg), a once-weekly hormone therapy patch used to treat menopausal symptoms and prevent postmenopausal osteoporosis.
Climara Pro is a registered trademark of Bayer. The FDA approved Zydus Pharmaceuticals’ generic estradiol and levonorgestrel transdermal system, aligning with its Public Health Pillar: “Increasing Access to Affordable Medicines & Medical Products.”
The patch is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus. It is also indicated for the prevention of postmenopausal osteoporosis.
“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.
Climara Pro and its generic version contain both estrogen and progestogen in a single patch, unlike estrogen-only patches commonly used in menopause treatment. The products are specifically approved for women with an intact uterus, as the progestogen component helps reduce the risk of endometrial hyperplasia, a condition that can develop with estrogen use alone.
“Once-weekly dosing can make a real difference in how patients manage their care. A patch offers a convenient alternative to daily oral medications, which may help patients stay on track with their treatment,” said Michael Davis, director of the FDA’s Center for Drug Evaluation and Research.
The approval aligns with the FDA’s Public Health Pillar, which focuses on increasing access to affordable medicines and medical products.
Zydus said the product will be manufactured at the group’s facility in Moraiya, near Ahmedabad, Gujarat.
Warnings and contraindications
The US FDA noted thatClimara 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, reported in at least 5% of patients, include application-site reactions, vaginal bleeding, breast pain, upper respiratory tract infection, back pain, depression, pain, headache and flu syndrome.
