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Femtrace Approved for Menopausal Symptoms

Kate Traynor

The Food and Drug Administration (FDA) on Friday gave Warner Chilcott PLC approval to market Femtrace oral estradiol acetate tablets for the relief of menopausal vasomotor symptoms.

The oral product was not approved for the treatment of vulvar-vaginal atrophy, an indication FDA granted last year for Femring, Warner Chilcott's estradiol acetate vaginal ring product.

Labeling for the new product is not yet available. In general, estrogens are contraindicated in women with abnormal genital bleeding or a known or suspected pregnancy. Estrogens are also contraindicated in women with known or suspected estrogen-dependent neoplasm; known, suspected, or past nonmetastatic breast cancer; or active or past thrombosis or thromboembolic disease.

Femtrace will be available in three strengths—0.45, 0.9, and 1.8 mg per tablet. The company said it plans to launch the product during the first quarter of 2005.