Historic first in women's sexual health: FDA grants approval for Addyi (flibanserin) in post-menopausal women

Sprout Pharmaceuticals

15 December 2025 -  Sprout Pharmaceuticals today announced a monumental milestone for women's health: the US FDA has approved Addyi (flibanserin 100 mg) for the treatment of hypoactive sexual desire disorder in women <65 years. 

This long awaited decision closes a gap in care for millions of post-menopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA.

Read Sprout Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration