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OTC Prilosec Risk/Benefit Ratio Relative To Current OTCs Questioned By Andrx

This article was originally published in The Tan Sheet

Executive Summary

Uncertainties about the safety and efficacy of OTC Prilosec (omeprazole 20 mg) combined with "the relative effectiveness" of currently available nonprescription acid-reducers, should cause FDA to deny Procter & Gamble/AstraZeneca's switch NDA, Andrx says in a Nov. 20 citizen petition

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A lack of data supporting consumer confusion claims between nonprescription Prilosec and the eponymous Rx version is cited by FDA in a letter denying a citizen petition. The petitioner sought an agency-mandated name change

Prilosec OTC Forced Name Change Rejected As FDA Clears Pending Petitions

A lack of data supporting consumer confusion claims between nonprescription Prilosec and the eponymous Rx version is cited by FDA in a letter denying a citizen petition. The petitioner sought an agency-mandated name change

Prilosec OTC Forced Name Change Rejected As FDA Clears Pending Petitions

A lack of data supporting consumer confusion claims between nonprescription Prilosec and the eponymous Rx version is cited by FDA in a letter denying a citizen petition. The petitioner sought an agency-mandated name change

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