With First Advertising Letter In 12 Months, US FDA Goes After Xeris’s Webpage Promotion Of Recorlev

The US Food and Drug Administration’s Office of Prescription Drug Promotion has not cited a company for advertising violations since last June so its untitled letter to Xeris Biopharma Holdings, Inc. is notable for showing the kind of behavior that will evoke a complaint.

OPDP objected to two webpages of the consumer website for Xeris’s Recorlev (levoketoconazole) saying they make misleading statements about the findings of two clinical studies and minimize serious and significant risks associated with the drug’s use