OPDP issues third enforcement letter of 2017
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.
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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.