By Ellyn Vohnoutka, MSHC, BSN, RN HealthDay Reporter
WEDNESDAY, Oct. 21, 2026 (HealthDay News) — Women looking for relief from menopause symptoms could soon have a more affordable option for a weekly hormone patch.
The U.S. Food and Drug Administration (FDA) approved the first generic version of Climara Pro on Monday. It’s a skin patch that delivers two hormones: estradiol, a form of estrogen, and levonorgestrel, a progestin.
Made by Zydus Pharmaceuticals (USA) Inc., the generic works the same way as the brand-name version, the agency said. Women apply a new patch once a week.
Like Climara Pro, it’s approved for women who still have a uterus. It treats moderate to severe hot flashes and night sweats caused by menopause. It also helps prevent osteoporosis, the bone-thinning disease that can follow menopause.
“Menopause is a universal experience for women, and it can greatly affect a person’s quality of life,” Acting FDA Commissioner Kyle Diamantas said in a news release. “This approval makes effective treatment more accessible.”
Many menopause patches contain estrogen alone. This one pairs estrogen with a progestin, a lab-made hormone that acts like the body’s natural progesterone.
That second hormone serves a purpose. In women with a uterus, estrogen on its own can cause the uterine lining to grow too thick. Adding a progestin helps protect against it and against uterine cancer, according to the FDA.
“Once-weekly dosing can make a real difference in how patients manage their care,” said Dr. Michael Davis, director of the 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.”
The approval comes as the FDA works to change how hormone therapy risks are presented.
The agency has asked drugmakers to remove language about heart disease, breast cancer and probable dementia from the boxed warnings on these products. Boxed warnings are the FDA’s most prominent safety alerts.
Those risks will still appear in another section of the labels. But fears about them have kept millions of women away from hormone therapy since the early 2000s, the FDA has said.
The most common side effects of the patch include skin irritation where it’s applied, vaginal bleeding, breast pain, headache and back pain.
Women who have had breast cancer, blood clots or liver disease, or who have unexplained vaginal bleeding, shouldn’t use it.
In the United States, 9-in-10 filled prescriptions are for generic drugs. More generic options create competition, which can lower prices and make treatment available to more people, the FDA noted.
Climara Pro is made by Bayer. Zydus, maker of the generic version, is expected to release more information on when it will be available.
More information
Visit the Cleveland Clinic for more information about hormone therapy for menopause.
SOURCES: U.S. Food and Drug Administration, Oct. 20, 2026; U.S. Food and Drug Administration, Feb. 13, 2026
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