“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies, said Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, testified on June 4 before two U.S. Food and Drug Administration advisory committees urging the agency to reject flibanserin – as the agency did in 2010 and 2013.