FDA Requires Label Change for Testosterone Products

fda requireds label change for low testosterone products

The FDA has announced that it is requiring manufacturers of all prescription testosterone products to update their labeling to clarify the approved uses for testosterone medications. The FDA wanted to make it clear in the labeling that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions, such as hypogonadism. The FDA reiterated that “the benefit and safety of prescription testosterone medications have not been established for treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”