TherapeuticsMD Inc. said the U.S. Food and Drug Administration approved its medicine Imvexxy to treat moderate to severe dyspareunia, or vaginal pain associated with sexual activity.
The condition is a symptom of vulvar and vaginal degeneration, which affects an estimated 32 million postmenopausal women in the U.S., the Boca Raton, Fla.-based women's healthcare products company said in a statement.
Imvexxy will be available for commercial distribution in July.
As part of the FDA's approval, TherapeuticsMD has agreed to conduct a post-approval observational study.
