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FDA Approves 10 mcg Dose of Vagifem for the Treatment of Atrophic Vaginitis Due to Menopause

Posted 2 Dec 2009 by Drugs.com

PRINCETON, N.J., Dec. 2 /PRNewswire-FirstCall/ – Novo Nordisk said today that the U.S. Food and Drug Administration (FDA) has approved a 10 mcg dose formulation of Vagifem (estradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause - a condition experienced by up to 75 percent of postmenopausal women. This approval makes Vagifem 10 mcg the lowest local estrogen therapy (LET) dose commercially available in the U.S. It will be available in pharmacies in the first quarter of 2010. Atrophic vaginitis, commonly referred to as vaginal atrophy, is directly related to the loss of estrogen associated with menopause. It is caused by the resulting thinning and shrinking of vaginal tissues and the decreased lubrication of the vaginal walls, which can lead to vaginal dryness, soreness, vaginal and or vulvar itching and irritation, painful sexual intercourse and light ... Read more

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