FDA WARNING_LETTER - Novartis Pharmaceuticals Corp - September 25, 2008

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a Warning Letter to Novartis Pharmaceuticals Corporation regarding promotional materials for Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules CII. The review of a professional slide deck (FCL-MD-0057-A) and a webpage for Focalin XR found them to be false or misleading, overstating efficacy and broadening the drug's indication, thus misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a) & (n)) and FDA regulations (21 CFR 201.100(c)(1), 201.128, 202.1(e)(6)(i)).

The materials misleadingly imply Focalin XR can mitigate consequences of untreated ADHD (e.g., low self-esteem, academic limitations, substance abuse, legal problems, impaired relationships, motor vehicle accidents, occupational difficulties) and achieve desired treatment outcomes (e.g., paying bills, avoiding speeding, decreased substance use). The FDA states that while Focalin XR improves ADHD symptoms, there's no substantial evidence it affects these broader outcomes.

Furthermore, the materials misleadingly claim long-term effectiveness and symptom control for Focalin XR, despite the FDA-approved labeling stating that effectiveness for long-term use (more than 7 weeks