
FDA approved the first generic patch equivalent to Climara Pro, a once-weekly hormone therapy for women with an intact uterus.
The patch delivers estradiol, an estrogen, and levonorgestrel, a progestogen, through the skin once each week.
For women with an intact uterus, FDA approved it to treat moderate to severe vasomotor symptoms due to menopause.
Its other approved use is preventing osteoporosis after menopause; the announcement does not say it treats established osteoporosis.
FDA says the progestogen component reduces the risk of endometrial hyperplasia, an overgrowth of the uterine lining that can occur with estrogen
Contraindications include undiagnosed abnormal bleeding, certain cancers and blood clots, liver disease, hypersensitivity, and some blood-clotting disorders.
FDA gave no price or pharmacy launch date, and directed readers to the manufacturer for availability information.
Read the FDA announcement for its complete approval details, listed side effects, contraindications, and note about checking with the manufacturer for availability.