Pfizer to pay $55M in drug misbranding
WASHINGTON — The Justice Department says Pfizer Inc. will pay $55 million to resolve allegations that Wyeth LLC promoted the drug Protonix for uses that were not approved by the Food and Drug Administration. Pfizer acquired Wyeth in October 2009.
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 leaks backwards from the stomach into the esophagus.