The FDA is committed to supporting the development of therapies for medical conditions related to female sexual dysfunction. The agency has approved treatments for pain during sexual intercourse and vaginal dryness associated with menopause. Additionally, the FDA has also identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. The agency will be actively soliciting patients’ perspectives on their condition and its impact on daily life.
The FDA cannot discuss any drug that is still under regulatory consideration. The agency evaluates drugs based on science and strongly rejects claims of gender bias. Currently, the FDA continues to work with the company to determine whether the drug’s benefits could outweigh its risks. The FDA strives to protect and advance all important areas of women’s health, and the agency is committed to working with companies to develop safe and effective treatments for female sexual dysfunction.