On June 2, 2022, the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter [1] to Althera Pharmaceuticals, LLC (Althera) relating to promotional communication for ROSZET® (rosuvastatin and ezetimibe) tablets for oral use (Roszet). The promotional communication was a professional “Roszet Doctor Info Letter Size”. [2] This is the third untitled letter from OPDP this year. In January, OPDP sent an untitled letter to Eli Lilly & Company regarding promotional claims for TRULICITY® on social media. In March, OPDP sent an untitled letter—which we covered in our blog post here —to Bausch Health Companies for misleading statements for DUOBRII™ conveyed in a promotional video and healthcare professional website.
The FDA’s Office of Prescription Drug Promotion slapped its 3rd untitled letter of the year onto New Jersey-based Althera Pharmaceuticals earlier this month, with the agency saying the firm’s DTC ad created a misleading impression about the safety profile of its cholesterol drug Roszet (rosuvastatin and ezetimibe) and combined study results in an unorthodox way.