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Talk to a SpecialistTalk to a SpecialistAcelRx Pharmaceuticals made false or misleading claims about the risks and efficacy of DSUVIA (sufentanil sublingual tablet) in a banner advertisement and tabletop display, thereby misbranding the drug in violation of the Federal Food, Drug, and Cosmetic Act. The promotional materials failed to adequately communicate serious safety information, particularly regarding accidental ingestion risks and fatal respiratory depression concerns that are central to the drug's Risk Evaluation and Mitigation Strategy (REMS) and restricted use in certified medically supervised healthcare settings only. This violation was especially concerning given DSUVIA's detailed administration instructions and strong usage limitations designed to protect patients from potentially life-threatening overdose and accidental exposure risks.