Regulatory Focus™ > News Articles > OPDP Issues Third Warning of 2017

OPDP Issues Third Warning of 2017

Posted 28 November 2017 | By Zachary Brennan 

OPDP Issues Third Warning of 2017

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate).

FDA said both Zolpimist’s webpage, supported by Amherst Pharmaceuticals, and exhibit panels appearing at the 2017 Annual Meeting of the Associated Professional Sleep Societies “fail to communicate any risk information. 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 letter also notes other misleading claims, such as that Zolpimist is clinically superior in efficacy to other oral zolpidem products in the treatment of insomnia because of its formulation and mode of delivery.

"No references are cited to support these claims of superior efficacy," FDA said, calling for a written response by Wednesday on whether the company intends to discontinue its use of such promotional materials or cease distribution of Zolpimist. Magna did not respond to a request for comment and Amherst’s website does not offer contact details.

In 2017, OPDP has now sent two warning letters and one untitled letter, which compares with three warning letters and eight untitled letters sent in 2016 and two warning letters and seven untitled letters in 2015.

Warning Letter


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe