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Effervescent ranitidine 75 mg tablet was not withdrawn from sale by Warner-Lambert due to safety or efficacy reasons, FDA says in a June 21 Federal Register notice, clearing the way for ANDA approvals.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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Effervescent ranitidine 75 mg tablet was not withdrawn from sale by Warner-Lambert due to safety or efficacy reasons, FDA says in a June 21 Federal Register notice, clearing the way for ANDA approvals.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 (Also see "Zantac 75 Efferdose petition" - Pink Sheet, 13 Mar, 2000.)). The agency will keep the product in the Orange Book's "Discontinued Drug Product List". |