Novo Nordisk A/S (NVO) announced that U.S. FDA has approved a 10 mcg dose formulation of Vagifem for the treatment of atrophic vaginitis due to menopause. The company said the approval is based on a randomized, placebo-controlled 52-week multicenter trial, which found statistically significant improvement with Vagifem 10 mcg versus placebo after 12 weeks treatment. The company noted that one year of continuous treatment with Vagifem 10 mcg tablets was also safe and well-tolerated by patients.
Vagifem was first approved as a 25 mcg tablet in the U.S. in 1999 and in 1988 in Europe.
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