FDA issues untitled letters to Sanofi and Viatris for false advertising
The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.
Sanofi
FDA issued an untitled letter to Sanofi in Morristown, NJ, concerning misleading claims made in an email regarding its drug, Beyfortus (nirsevimab-alip). Beyfortus is a long-acting monoclonal antibody injection intended to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in newborns and infants.
The agency indicated that the company’s advertisements created a misleading impression by suggesting that Beyfortus can be used for the general prevention of RSV, including both upper and lower respiratory tract diseases, which is incorrect.
FDA has approved this product to prevent RSV in the lower respiratory tract, not in both respiratory tracts.
The agency said that “by failing to adequately communicate the indication for Beyfortus, the emails create a misleading impression about the drug’s FDA-approved indication.”
This is the second untitled letter Sanofi has received since FDA began its crackdown on drug advertisers last September. (RELATED: FDA posts more than 100 warning and untitled letters in ad crackdown, Regulatory Focus 16 September 2025).
FDA issued an untitled letter last September to Sanofi regarding its promotional communication, in a direct-to-consumer (DTC) television advertisement for Tzield, (teplizumab-mzwv) injection, which is used intravenously o treat type 1 diabetes.
Viatris
FDA also issued an untitled letter to Viatris regarding the promotional claims made in a direct-to-consumer TV advertisement for its TOBI Podhaler (tobramycin inhalation powder). This prescription aminoglycoside antibiotic is used to treat chronic lung infections caused by pseudomonas aeruginosa in adults and children aged six years and older who have cystic fibrosis.
The agency disputed the advertisement's claim that the product is portable and can be administered quickly, such as in a car.
FDA said that “these claims create the misleading impression that patients can perform the administration process for TOBI Podhaler anywhere, such as “in the car” or “while running out of the door on the way to school,” without problems.
The agency stated that its FDA-approved Instructions for Use (IFU) for the TOBI Podhaler include several detailed steps that require adequate lighting and stable conditions for proper preparation and administration of the product. These steps involve washing and drying of hands, placing the mouthpiece on a clean, dry surface, and holding the capsule up to the light to ensure that it is empty, with only a fine coating of powder remaining on the inside surface.
“FDA has determined that the video is false or misleading. Thus, the video misbrands TOBI Podhaler and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
