FDA Approves Generic Vaginal Inserts for Treatment of Menopause Symptoms

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.²Hormone 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.

The North American Menopause Society notes that vaginally inserted hormone therapy is safe and effective, as the estrogen directly moisturizes and rebuilds vaginal tissue. Vaginal insert hormone therapy has fewer risks than other hormonal therapies, as very little estrogen enters the blood stream.³

While hormone therapy is safe to treat moderate to severe menopause symptoms within 10 years of menopause and up to age 59, researchers note that women should use the lowest dose available for the shortest possible time, according to the HHS’ Office on Women’s Health.²

The newly approved generic vaginal inserts will be available in 10 microgram doses, according to Glenmark.¹

References

1. Glenmark Pharmaceuticals Receives ANDA Approval for Estradiol Vaginal Inserts USP, 10 mcg [news release]. Mumbai, India; September 17, 2018: Glenmark Pharmaceuticals Inc. Accessed September 17, 2018.
2. US Department of Health and Human Services’ Office on Women’s HealthMenopause. HHS website.https://www.womenshealth.gov/menopause. Updated May 23, 2018. Accessed September 17, 2018.
3. Hormone Therapy and Menopause FAQs. The North American Menopause Society website.www.Menopause.org. Accessed September 17, 2018.