The FDA has approved the first generic of Climara Pro, a once-weekly transdermal hormone therapy patch for women with an intact uterus.
The estradiol and levonorgestrel transdermal system, 0.045 milligrams per day/0.015 milligrams, is therapeutically equivalent to Climara Pro, according to an Oct. 20 FDA release. It is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and the prevention of postmenopausal osteoporosis.
The patch contains both estrogen and progestogen. The progestogen component is included to reduce the risk of endometrial hyperplasia that can occur with estrogen use alone.
The approval comes as pharmacies struggle to supply estradiol patches, though this product does not directly address that problem. The shortage involves estrogen-only estradiol patches, which ASHP has listed in short supply since January. The FDA said Sept. 3 it is working with six manufacturers to boost supply, noting production has nearly doubled over the past year, and pharmacists in Pittsburgh reported supply constraints lasting six to eight months. Demand rose after the FDA asked in November to remove boxed warnings from menopausal hormone therapy products.
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