FDA WARNING_LETTER - Elanco Animal Health USA - January 08, 2026

On January 8, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Elanco Animal Health USA, citing false and misleading promotional claims for their product, Pradalex (pradofloxacin injection). The FDA reviewed various promotional communications, including print advertisements, detail aids, a technical manual, and videos, noting issues with the representation of the product"s safety and effectiveness. The main violations included recommending Pradalex for “First-pull treatment” of Bovine Respiratory Disease (BRD) and Swine Respiratory Disease (SRD), which contradicts the FDA-approved label stating it should only be used after considering non-fluoroquinolone options due to critical antimicrobial resistance concerns. Furthermore, Elanco falsely claimed Pradalex was “Effective for the treatment of all relevant BRD pathogens” and “all relevant SRD pathogens,” overstating its approved indications and potentially promoting prohibited extralabel use. Lastly, comparative claims like “2x the power in less than half the time” were found misleading, as they implied general effectiveness and rapid treatment based on in vitro data rather than clinical outcomes. These promotional practices led to the product being misbranded under sections 502(a), 502(n), and 201(n) of the Federal Food, Drug, and Cosmetic Act. Elanco is required to submit a written response within fifteen working days, detailing a plan to discontinue the non-compliant communications or cease Pradalex distribution, and addressing the identified concerns.