FDA Press Releases·Oct 20, 2026, 12:02 PM ET

FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women

On October 19, 2026, the FDA approved the first generic version of Climara Pro (estradiol & levonorgestrel transdermal system).
Zydus Pharmaceuticals (USA) Inc. received approval for the generic product, which is therapeutically equivalent to the brand-name drug.
The once-weekly patch is indicated for treating moderate to severe vasomotor symptoms due to menopause & preventing postmenopausal osteoporosis in women with an intact uterus.
The combination of estrogen & progestogen in this patch reduces the risk of endometrial hyperplasia associated with estrogen-only use.
Common adverse reactions (occurring in 5% or more of patients) include application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache, & flu syndrome.
The medication is contraindicated for patients with undiagnosed abnormal genital bleeding, breast cancer, estrogen-dependent neoplasia, active or history of DVT/PE, arterial thromboembolic disease, hypersensitivity to components, hepatic impairment, or specific thrombophilic disorders.
This approval supports the FDA's Public Health Pillar goal of increasing access to affordable medicines & medical products.