The FDA’s Office of Prescription Drug Promotion issued a warning letter to Amherst Pharmaceuticals and Magna Pharmaceuticals over the promotion of insomnia drug Zolpimist.
The agency’s letter charged the drugmakers with failing to include significant risk information in a page on Amherst’s website and in an exhibit panel. Amherst has the exclusive rights to market Zolpimist.
The companies did not respond to request for comment by publication time.
OPDP officers wrote that the “misleading presentation is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”
This is the agency’s third enforcement letter issued in 2017. Last year, the OPDP sent 11.