Please refer to your supplemental new drug application (sNDA) dated and received August 29, 2019, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act...

The NDC Packaged Code 58604-214-30 is assigned to a package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Addyi, a human prescription drug labeled by Sprout Pharmaceuticals, Inc..

02. More Satisfying Sex** 03. Less Stress (From Low Libido) *Efficacy of Addyi was established in three 24-week trials in over 2,000 women with acquired, generalized HSDD. Patients were treated with …

Pursuant to 21 CFR 208, FDA has determined that ADDYI poses a serious and significant public health concern requiring the distribution of a Medication Guide. The Medication Guide is necessary for...

The efficacy of Addyi (flibanserin) was established in three North American randomized, placebo‐controlled trials involving 2409 premenopausal women.

(DTC) radio advertisement (radio ad) (US—1900289.03) for ADDYI (flibanserin) tablets, for oral use (Addyi) submitted by Sprout Pharmaceuticals (Sprout) under …

Please refer to your New Drug Application (NDA) dated and received October 27, 2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Addyi...

Jun 10, 2025 · This broad claim suggests that Addyi is indicated, among other things, to enhance sexual performance, which is particularly concerning given the limitations of use and serious risks of this...

This is the third review cycle for flibanserin (tradename Addyi), a new molecular entity proposed for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

Please refer to your supplemental new drug application (sNDA) dated and received on March 17, 2025, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act...