The agency found that an exhibit panel at a conference made false claims about the drug’s benefits over generic dexamethasone without providing adequate risk information, according to an FDA letter issued to the drugmaker.
According to the letter, the promotional materials suggested Hemady led to better patient adherence compared to generic dexamethasone. However, the study cited to support the claim contained flaws, including inconsistent patient selection criteria, lack of control for key variables and an unbalanced sample size.
The FDA has demanded that Dexcel discontinue these practices and respond within 15 working days with a plan to address the violations, warning that failure to do so would result in further regulatory action.
