Recent FDA Letters Fault Three Companies’ Drug Promotional Items as False, Misleading

The Food and Drug Administration has told Pfizer Inc., Acorda Therapeutics Inc., and Valeant Pharmaceuticals North America LLC that promotional materials for their drug products are false or misleading, according to “untitled” letters posted recently on FDA’s website.

The materials the agency objects to include promotional brochures, videos, and a web page. An FDA untitled letter cites violations that do not meet the threshold of regulatory significance for an FDA warning letter, according to the agency’s regulatory procedures manual.

Pfizer’s Zmax Brochure.

In a June 19 letter to Pfizer, FDA said a brochure for Zmax (azithromycin extended release) for oral ...