FDA’s Second Untitled Letter of the Year – An Apparently Tough Choice Between Raising Awareness and Public Safety for Anaphylaxis Drugs

On July 17, 2024—but just recently posted to the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) website—FDA issued its second untitled letter (letter) of the year to Kaleo, Inc. (Kaleo) over social media promotion of AUVI-Q® (epinephrine injection, USP). The social content was posted on the personal Instagram account of Brittany Mahomes—yes, that Mahomes……
By: Sheppard Mullin Richter & Hampton LLP