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Zantac 75 Efferdose

This article was originally published in The Tan Sheet

Executive Summary

Effervescent ranitidine 75 mg tablet was not withdrawn from sale by Warner-Lambert due to safety or efficacy reasons, FDA says in a June 21 Federal Register notice, clearing the way for ANDA approvals. Although the OTC was approved in February 1998 for heartburn treatment and received a prevention indication in March 1999, W-L has never marketed it. Responding to a citizen petition filed in February by regulatory strategist Thomas Blake, PhD, FDA determines "never marketing an approved drug product is equivalent to withdrawing the drug product from sale" (1"The Tan Sheet" March 13, In Brief). The agency will keep the product in the Orange Book's "Discontinued Drug Product List"

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Zantac 75 Efferdose petition

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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