Press Releases

Sept 11, 2019, 08:30 ET

Summary of Recent Regulatory Guidance for Addyi®, the First and Only Pill for Hypoactive Sexual Desire Disorder

The following provides a recent timeline of events between the U.S. Food and Drug Administration (FDA) and Sprout Pharmaceuticals as it relates to regulatory guidance on Addyi’s labeling.

Apr 12, 2019, 11:55 ET

The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol

Sprout continues to work with FDA to ensure other elements of labeling are in line with new study findings