FDA Issues Untitled Letter to NJ Drugmaker for Misleading Cancer Drug Claims at Conference

The FDA issued an untitled letter to Edenbridge Pharmaceuticals (now known as Dexcel Pharma USA) over misleading claims made about its multiple myeloma drug Hemady at a conference exhibit booth13.
The exhibit booth panel only presented efficacy claims for Hemady but did not include any warnings or precautions, which the FDA found concerning from a public health perspective3.
The FDA said the omission of risk information creates a misleading impression about the benefits of Hemady for treating multiple myeloma, an incurable disease3.
The display also included a table suggesting Hemady was more effective than generic versions, which the FDA said was not supported by the company's research due to study limitations3.
This was the first untitled letter issued by the FDA's Office of Prescription Drug Promotion in 20241.
An untitled letter cites violations that do not meet the threshold for a warning letter, but still requires a response from the company3.
The FDA requested Edenbridge reply within 15 working days with a plan to discontinue the misleading materials3.

Sources:

1. https://endpts.com/misleading-promotion-lands-nj-drugmaker-a-letter-from-fda/

3. https://njbiz.com/fda-alerts-nj-pharma-for-misleading-cancer-drug-claims-at-conference/