Teva Pharmaceutical Industries Ltd. announced the launch of an authorized generic of Estrace Cream (estradiol vaginal cream, USP, 0.01%), in the U.S. Estradiol vaginal cream, USP, 0.01%, is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. This launch is an important addition to Teva’s generic women’s health portfolio and growing line of menopause treatments. Estradiol Vaginal Cream 0.01% had annual sales of approximately $426 million in the U.S., according to IMS data as of August 2017. Indications and usage: Estradiol Vaginal Cream, USP is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Endometrial cancer, cardiovascular disorders, breast cancer and probable dementia: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women with daily oral conjugated estrogens (CE) alone. The WHI estrogen-plus-progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women with daily oral CE combined with medroxyprogesterone acetate (MPA). In the absence of comparable data, these risks should be assumed to be similar for other dosage forms of estrogens. The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens-plus-medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen-alone therapy. The WHI estrogen-plus-progestin substudy demonstrated an increased risk of invasive breast cancer. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estradiol Vaginal Cream, USP should not be used in: women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active arterial thromboembolic disease (for example, stroke, myocardial infarction) or a history of these conditions; known anaphylactic reaction or angioedema to Estradiol Vaginal Cream, USP; liver dysfunction or disease; thrombophilic disorders; known or suspected pregnancy. Estrogens increase the risk of gallbladder disease. Discontinue estrogen if hypercalcemia, sudden partial or complete loss of vision, hypertriglyceridemia, or cholestatic jaundice occurs. Patients dependent on thyroid hormone replacement therapy should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. Endometriosis may be exacerbated in women treated post-hysterectomy with estrogen-alone therapy. The addition of progestins should be considered in these patients. The most common side effects include: headache, breast tenderness, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, and vaginal burning, irritation, and itching. Systemic absorption may occur with the use of Estradiol Vaginal Cream, USP. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.