Sprout Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Addyi (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. "This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized," says Cindy Eckert, founder and CEO of Sprout Pharmaceuticals. "Over the years, we've pushed for the science to speak louder than the stigma—and today's approval shows how far we've come. I want to congratulate the FDA for recognizing what millions of women have long deserved: equitable, science-backed care at every stage of life."
The expanded approval of Addyi follows the FDA's Priority Review designation announced earlier this year, a status reserved for drugs that represent meaningful improvements in the treatment for serious unmet medical needs. This designation underscores the agency's increasing commitment to addressing long-standing gaps in women's health and ensuring timely access to evidence-based care.