Zantac 75 Efferdose petition
This article was originally published in The Tan Sheet
Executive Summary
Regulatory strategist Thomas Blake, PhD, asks FDA whether Warner-Lambert is not marketing Zantac 75 Efferdose due to "reasons of safety or efficacy" in a Feb. 29 citizen petition. The effervescent ranitidine 75 mg product initially was approved for heartburn treatment in February 1998 and was granted a prevention indication in March 1999. Warner-Lambert says the status of the product is unclear