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Treats moderate to severe vasomotor symptoms due to menopause. ANDA 211396, held by Amneal. Estradiol.
As of Nov 14, 2026, ANDA 211396 (Estradiol), held by Amneal, was first approved by FDA on Sep 28, 2020, with 2 approved supplements and 0 published complete response letters.
First approved: Sep 28, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
LYLLANA is indicated for: LYLLANA is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause Prevention of postmenopausal osteoporosis Limitations of Use When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
