FDA Approves Generic Estradiol Gel for Postmenopausal Symptom Relief
• The FDA has approved a generic estradiol gel, 0.06% (ANI Therapeutics), for treating moderate to severe hot flashes and vaginal changes due to menopause.
• The topical gel, a generic version of EstroGel, is administered daily and may require progestin co-administration in women with a uterus to reduce endometrial cancer risk.
• Clinical studies showed estradiol gel reduced hot flash frequency by approximately 75% and improved vaginal dryness severity by about 50% in menopausal women.
• US annual sales for estradiol gel were approximately $16.7 million, and this generic option aims to provide a more accessible and affordable treatment for patients.
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