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FDA Approves Estradiol Gel, 0.06% for Women Post-Menopause

FDA approved estradiol gel, 0.06% (ANI Therapeutics) for reducing moderate to severe hot flashes and vaginal changes post-menopause, also treating symptoms from ovarian removal, prostate/breast cancer, and preventing osteoporosis. The gel, applied daily to the arm, contains 0.75 mg of estradiol per 1.25 g pump. Progestin is recommended for women with a uterus to reduce endometrial cancer risk. Common adverse events include headache, flatulence, and breast pain, with serious risks like cardiovascular disorders and malignant neoplasms. US annual sales for estradiol gel were $16.7 million in August 2024.
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