FDA approves Novo Nordisk's atrophic vaginitis treatment

PRINCETON, N.J. The Food and Drug Administration has approved a 10-microgram formulation of a suppository for treating atrophic vaginitis.

Danish drug maker Novo Nordisk announced Wednesday the approval of Vagifem (estradiol), saying that the 10 microgram formulation makes it the lowest local estrogen therapy dose commercially available in the United States. The drug will reach pharmacy shelves during first quarter 2010, the company said.

Atrophic vaginitis affects up to 75% of postmenopausal women, causing thinning and shrinking of vaginal tissues that leads to dryness, soreness and irritation.

The 25 microgram formulation was approved in the United States in 1999.