- Regulators from the Food and Drug Administration have issued a rare warning letter to Magna Pharmaceuticals Inc. for neglecting to present any risk information in promotional materials for a generic version of the prescription sleep aid zolpidem, more commonly known by its branded name Ambien.
- The small generic drugmaker's website, along with exhibits showcased by the company at a 2017 conference, omitted any mention of the copycat drug's safety while making unsubstantiated claims suggesting the spray formulation of zolpidem outperformed branded Ambien tablets, the FDA wrote.
- The caution, which demands Magna stop using the materials in question, is only the third such letter issued by the FDA's Office of Prescription Drug Promotion (OPDP) this year, continuing a sharp decline in activity over the past decade.
Magna's Zolpimist (zolpidem tartrate) comes with warning against the drug's depressive effect on the central nervous system, the potential for depression and severe anaphylactic reactions, among other side effects.
The drugmaker mentioned none of these safety issues in its promotion of the drug.
"By omitting the risks associated with Zolpimist, the webpage and the exhibit panels fail to provide material information about the consequences that may result from the use of the drug and create a misleading impression about the drug’s safety," the FDA wrote in its warning letter dated Nov. 14.
FDA regulators took particular note of Magna's claims that Zolpmist's oral spray formulation conferred superior clinical benefits, such as a faster onset of action.
Magna's website — which appears to have been modified to reflect the FDA's warning — also touted that its spray version does not have reduced efficacy when taken with food; a known limitation of the oral compound. Yet, Zolpimist's prescribing information states the drug's effect may be slowed by ingestion with or immediately after a meal.
In its letter, the OPDP demands Magna, which licensed Zolpimist from Amherst Pharmaceuticals LLC in 2015, cease misbranding Zolpimist and disseminate corrective messaging.
As the OPDP's enforcement activity has declined in recent years, it has focused its efforts on smaller drugmakers that omit proper risk information. The two other letters issued in 2017 cite similar violations by Cipher Pharmaceuticals Inc. and Orexigen Therapeutics Inc.