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FDA Expands Addyi Approval to Women Over 65

12/16/2025

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FDA Expands Addyi Approval
  • The U.S. Food and Drug Administration expanded Addyi's approval to postmenopausal women over 65.
  • The FDA announced the decision on December 15, 2025.
  • Addyi was first approved in 2015 for premenopausal women and carries dizziness and nausea as side effects, with a serious warning against alcohol.
  • The approval followed years of lobbying framed as a women's rights issue, while diagnosing low sexual desire remains complex, influenced by factors after menopause.
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