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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
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