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FDA OKs libido-boosting pill for older women who have gone through menopause
FDA approval of Addyi now covers postmenopausal women under 65, addressing a common sexual health disorder affecting an estimated 40% of women, experts say.
- On Dec. 15, 2025, the U.S. Food and Drug Administration approved Addyi for postmenopausal women under age 65, Sprout Pharmaceuticals announced.
- After a decade of regulatory scrutiny, the expanded approval follows FDA Priority Review earlier this year and builds on flibanserin's 2015 approval plus published SNOWDROP trial data.
- Clinical data show that a 24-week randomized, double-blind, placebo-controlled trial reported significant increases in satisfying encounters and desire .
- Sprout CEO Cindy Eckert framed the decision as a milestone, saying `This milestone reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized`, and Addyi is already prescribed by over 30,000 U.S. healthcare professionals.
- Despite approval, safety measures such as prior Risk Evaluation and Mitigation Strategy and alcohol guidance remain central, as the drug retains a boxed warning about alcohol-linked hypotension and fainting while some psychologists question the HSDD diagnosis.
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Anti-Aging, Acupuncture and Health NewsFDA Approves Sexual Desire Drug for Postmenopausal Women
(MedPage Today) -- The FDA expanded the approval of flibanserin (Addyi), a drug that treats low sexual desire in women, to now include some postmenopausal women, drugmaker Sprout Pharmaceuticals announced on Monday. Flibanserin is a mixed 5-HT1A...
·New York, United States
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US health officials expanded approval of a much-debated drug intended to boost female sex drive, announcing that the daily pill can now be taken by women over 65.
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Total News Sources72
Leaning Left13Leaning Right9Center34Last UpdatedBias Distribution61% Center
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61% Center
L 23%
C 61%
R 16%
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