December 03, 2009
Vagifem 10mcg approved for atrophic vaginitis due to menopauseThe FDA has approved a 10mcg formulation of Vagifem (estradiol vaginal tablets, from Novo Nordisk) for the treatment of atrophic vaginitis due to menopause. This approval is based on clinical data from a 52-week, multicenter, randomized, placebo-controlled trial that found statistically significant improvement with Vagifem 10mcg compared to placebo after 12 weeks of treatment in the relief of bothersome symptoms (eg, vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, pain with urination, painful intercourse, and vaginal bleeding associated with intercourse) and in the correction of important biological markers (vaginal pH, vaginal maturation index) to levels seen in non-menopausal women.
Vagifem is already available as a 25mcg vaginal tablet. Vagifem 10mcg is expected to be available in the first quarter of 2010.
For more information call (800) 727-6500 or visit www.vagifem.com.