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Addyi FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved August 18, 2015)
Brand name: Addyi
Generic name: flibanserin
Dosage form: Tablets
Company: Sprout Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Addyi (flibanserin) is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.

Development timeline for Addyi

DateArticle
Apr 11, 2019FDA Orders Important Safety Labeling Changes for Addyi Regarding Alcohol Consumption
Aug 18, 2015Approval FDA Approves Addyi (flibanserin) for Hypoactive Sexual Desire Disorder in Premenopausal Women
Jun  4, 2015FDA Advisory Committee Recommends Approval for Addyi (flibanserin) to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women
Feb 17, 2015Sprout Pharmaceuticals Resubmits Flibanserin NDA for Hypoactive Sexual Desire Disorder In Premenopausal Women
Feb 11, 2014Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit NDA for Flibanserin
Dec 11, 2013Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women
Oct  8, 2010Following Regulatory Feedback Boehringer Ingelheim Decides to Discontinue Flibanserin Development
May 19, 2010Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder

See also

Addyi (flibanserin) Consumer information

Further information

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