Obstetrics & Gynecology · 2 h ago
FDA approves first generic once-weekly estradiol–levonorgestrel patch
The FDA has approved Zydus Pharmaceuticals’ generic estradiol and levonorgestrel transdermal system, the first generic of Climara Pro. The once-weekly combination patch is indicated for women with an intact uterus; the FDA says it is therapeutically equivalent to the branded product.
- First generic version of Climara Pro approved in the U.S.
- Combination patch is applied once weekly.
- Indicated for women with an intact uterus.
- FDA lists multiple contraindications and common adverse reactions.
The FDA approved the first generic version of Climara Pro: an estradiol and levonorgestrel transdermal system delivering 0.045 mg/day and 0.015 mg, respectively. The patch is applied once weekly and is indicated for women with an intact uterus. Zydus Pharmaceuticals (USA) Inc. received the approval; the agency did not provide availability information and advises contacting the manufacturer.
The combination contains estrogen and progestogen in one patch. The FDA notes that the progestogen component is included to reduce the risk of endometrial hyperplasia associated with estrogen use alone. The agency lists application-site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome among adverse reactions occurring in at least 5% of patients. Contraindications include certain cancers, thromboembolic conditions, hepatic disease and thrombophilic disorders. This is a regulatory approval, not new comparative clinical-trial evidence; the FDA describes the generic as therapeutically equivalent to Climara Pro.
In practice
For women with an intact uterus who are being considered for this hormone-therapy patch, the FDA approval establishes a generic option therapeutically equivalent to Climara Pro. The once-weekly patch combines estradiol with levonorgestrel; the progestogen is included to reduce the risk of endometrial hyperplasia associated with estrogen alone. This approval does not provide new comparative trial findings. The FDA lists important contraindications, including certain cancers, thromboembolic conditions, hepatic disease and thrombophilic disorders; availability was not specified.
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U.S. Food and Drug Administration: FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.