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Sprout Pharmaceuticals received a warning for false and misleading promotional claims about ADDYI (flibanserin) in a social media post by its CEO that highlighted benefits while completely omitting risk information and material limitations of the drug's use. The company failed to include required safety information about ADDYI's serious risks, including its boxed warning for severe hypotension and syncope, and did not submit the promotional material to FDA for review prior to publication as required by regulations. This violation was particularly concerning given that ADDYI is a drug with significant safety risks and a restricted indication limited to premenopausal women with acquired generalized hypoactive sexual desire disorder not attributable to medical, psychiatric, relationship, or medication-related causes.