FDA WARNING_LETTER - IPR Pharmaceuticals, Inc. - June 10, 2025

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Sprout Pharmaceuticals, Inc. regarding a social media post by CEO Cindy Eckert on Instagram for ADDYI (flibanserin) tablets. The post was deemed false or misleading because it promoted benefits without including any risk information or material details about the drug's full indication and limitations of use, thus misbranding Addyi under 21 U.S.C. 352(a), (n); 321(n); 331(a) and 21 CFR 202.1(e)(3)(ii), (iii); (e)(5).

Addyi has serious risks, including a boxed warning for severe hypotension and syncope. The post omitted crucial information about contraindications (e.g., with CYP3A4 inhibitors, hepatic impairment) and common adverse reactions (dizziness, somnolence). It also failed to specify Addyi's indication for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) not due to other conditions, and that it's not for postmenopausal women, men, or sexual performance enhancement.

Furthermore, the promotional material was not submitted to the FDA via Form FDA-2253 at the time of initial dissemination, violating 21 CFR 314.81(b)(3)(i). This is a repeat concern,