Pfizer to pay $55 million in drug misbranding case
The Justice Department says Pfizer Inc. will pay $55 million to resolve allegations that its subsidiary Wyeth LLC promoted the drug Protonix for uses that were not approved by the Food and Drug Administration.
In a written statement from its New York office, Pfizer, which acquired Wyeth in October 2009 years after the alleged misconduct, said that Pfizer was not a target or a subject of the case.
Wyeth obtained FDA approval to promote Protonix only for short-term treatment of erosive esophagitis. The condition is associated with gastro-esophageal reflux disease. Wyeth allegedly promoted Protonix for all forms of GERD from February 2000 to June 2001.
GERD is a condition in which food or liquid leak backwards from the stomach into the esophagus.
Pfizer's statement specifically denied allegations of wrongdoing.