FDA WARNING_LETTER - Nalpropion Pharmaceuticals LLC - September 29, 2020

The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Nalpropion Pharmaceuticals LLC concerning a sponsored Google link for CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets. The OPDP, along with a complaint from the FDA Bad Ad Program, found that the sponsored link made false or misleading claims about Contrave's risks and efficacy, thereby misbranding the drug under 21 U.S.C. 352(a), (n); 321(n); 331(a) and 21 CFR 202.1(e)(3)(ii); (e)(5).

Specifically, the link presented efficacy claims while entirely omitting critical risk information, including the boxed warning for suicidal thoughts and behaviors, creating a misleading impression of safety. Furthermore, it failed to disclose material information from the FDA-approved indication, such as the requirement for Contrave to be an adjunct to diet and exercise, specific initial BMI criteria, the need for weight-related comorbid conditions, and limitations of use. The promotion also selectively presented favorable efficacy data, implying broader applicability than approved.

These violations are particularly concerning given Contrave's serious, potentially life-threatening risks. OPDP noted a similar issue in a 2017 Untitled Letter to the previous application holder. Nalpropion is required to immediately cease misbranding Contrave and submit a written response by October 7, 2020. The response must detail a comprehensive plan to disseminate truthful, non-misleading corrective messages to the audience that received the violative promotional materials. Failure to comply may lead to FDA regulatory actions like seizure or injunction.