Outlook Pharmaceuticals, Inc. – FDA Warning Letter, Feb 21, 2020
The FDA's Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to Outlook Pharmaceuticals, Inc. regarding a sponsored Google.com link for ProCentra (dextroamphetamine sulfate) oral solution, CII. The link was found to be false or misleading because it presented benefits of ProCentra without including any risk information, thus misbranding the drug under 21 U.S.C. 352(a), (n); 321(n); 331(a) and 21 CFR 202.1(e)(5). This is particularly concerning as ProCentra is a Schedule II controlled substance for pediatric patients with a Boxed Warning for abuse potential, dependence, sudden death, and serious cardiovascular events.
Additionally, the sponsored link failed to present the required established name (dextroamphetamine sulfate) in conjunction with the proprietary name, violating 21 U.S.C. 352(e)(1)(B), (n); 331(a) and 21 CFR 201.10(g)(1); 202.1(b)(1). The promotional material's claims like "Explore Your ADHD Medication Options For Your Child," "Liquid Treatment Option," and "Bubblegum Flavor" were cited for appealing to parents without disclosing serious risks.
OPDP requested Outlook Pharmaceuticals immediately cease misbranding ProCentra and submit
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