Doral (quazepam) / Mallinckrodt - LARVOL DELTA

FDA’s OPDP warns insomnia drugmaker over Email (Regulatory Affairs Professionals Society) - "The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Atlanta-based Galt Pharmaceuticals for an email it sent that makes false or misleading claims related to its insomnia treatment Doral (quazepam), which FDA said are 'xtremely concerning from a public health perspective.'...The claims and presentation minimize the risks of abuse and dependence associated with Doral and suggest that the scheduled drug is superior in safety to other prescription and over-the-counter (OTC) products, OPDP said."

FDA event