FDA has approved the first generic version of Climara Pro, a hormone therapy patch applied once a week for women with an intact uterus. Its October 20 announcement says approval happened the previous day, placing the approval on October 19.
What was approved
The patch combines estradiol and levonorgestrel, an estrogen and a progestogen. FDA says the generic is therapeutically equivalent to Climara Pro and is approved to treat moderate to severe vasomotor symptoms due to menopause and to prevent postmenopausal osteoporosis.
The approval is specifically for women with an intact uterus. FDA explains that the progestogen component is included to reduce the risk of endometrial hyperplasia, an effect that can occur when estrogen is used alone. This combination patch differs from estrogen-only patches used in menopause treatment.
The approved product is Zydus Pharmaceuticals (USA) Inc.'s estradiol and levonorgestrel transdermal system. The announcement describes a once-weekly patch, not a daily oral medicine.
Who should not use it
FDA lists contraindications that include undiagnosed abnormal genital bleeding; breast cancer or a history of it; estrogen-dependent neoplasia; active or previous deep vein thrombosis or pulmonary embolism; and active or previous arterial thromboembolic disease.
The list also includes known anaphylactic reaction or angioedema or hypersensitivity to estradiol and levonorgestrel, liver impairment or disease, and protein C, protein S or antithrombin deficiency or other thrombophilic disorders. These are limitations in the approval announcement, not a determination that an individual patient is eligible.
The most common adverse reactions occurring in at least 5% of patients include application-site reactions, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome, according to FDA.
Approval is not an availability or price notice
FDA says additional generics can increase market competition and access. The announcement does not state a selling price or quantify savings for this product, so the approval does not establish what an individual patient will pay.
For information about the medicine's availability, FDA directs readers to contact the manufacturer. The announcement gives no commercial availability date.