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P&G Asks FDA To Make Prilosec The Standard For OTC PPI Claims

This article was originally published in The Tan Sheet

Executive Summary

Procter & Gamble is asking FDA to develop class labeling for OTC proton pump inhibitors that would effectively preclude all products in the category from claiming greater efficacy than P&G's Prilosec OTC

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Intangible Benefits Are Influential In OTC Switch Decisions – CDER’s Ganley

Non-measurable benefits can tip the scales in the benefit/risk consideration of an OTC switch NDA, suggests Charles Ganley, director of CDER's Office of Drug Evaluation IV. One way to look at non-measurable benefits is how OTC ingredients "lower the threshold” for patient “misery” prior to seeking relief, he says.

Intangible Benefits Are Influential In OTC Switch Decisions – CDER’s Ganley

Non-measurable benefits can tip the scales in the benefit/risk consideration of an OTC switch NDA, suggests Charles Ganley, director of CDER's Office of Drug Evaluation IV. One way to look at non-measurable benefits is how OTC ingredients "lower the threshold” for patient “misery” prior to seeking relief, he says.

FDA Denies P&G Petition For OTC Proton Pump Inhibitor Class Labeling

FDA's rejection of a Procter & Gamble citizen petition seeking class labeling for OTC proton pump inhibitors clears a roadblock for Schering-Plough's Zegerid to potentially make an "immediate release" claim

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