The U.S. Food and Drug Administration (FDA) has issued a warning letter to Nephron Pharmaceuticals Corporation due to emails Nephron’s CEO and a sales representative sent concerning its product Budesonide Inhalation Suspension, which were the subject of complaints submitted to the FDA Bad Ad Program.
The emails provide evidence that Budesonide is intended for a new use for which it lacks approval, specifically the treatment of symptoms associated with COVID-19, and for which its labelling does not provide adequate directions for use.
This renders Budesonide misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. The emails are also false or misleading in that they represent that Budesonide has certain benefits, but fail to include any risk information about the drug. This also renders Budesonide misbranded and makes its distribution violative.
These violations are concerning because they create a misleading impression about the safety and effectiveness of Budesonide for the treatment of COVID-19 and suggest a use for which the labeling does not provide adequate directions for safe and effective use of the product.
The complete warning letter is available on the FDA website.
Source : American Pharmaceutical Review