FDA OKs Generic Vaginal Inserts for Treatment of Menopause Symptoms – APhA submits compounding comments to FDA. – (866) 348-2889.
Generic estradiol vaginal inserts have have received final FDA approval to relieve the symptoms of menopause in women. Glenmark’s newly approved Estradiol Vaginal Inserts USP are equivalent to Novo Nordisk’s VAGIFEM.1
Menopause, the time when a woman’s menstrual cycle ends and she is no longer fertile, results in a reduction in both estrogen and progesterone production. Low levels of these 2 hormones can lead to symptoms such as hot flashes, sleep problems, painful sexual intercourse, mood changes, or depression and anxiety.2 Hormone therapy, such as estradiol vaginal inserts, can help replenish estrogen levels and reduce these symptoms, according to the US Department of Health and Human Services’ (HHS) Office on Women’s Health.