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P&G Says Zegerid Switch Proposal Should Drop “Immediate Release” Claim

This article was originally published in The Tan Sheet

Executive Summary

The proton pump inhibitor Zegerid should not be allowed on the over-the-counter market with the label claim "immediate release," says Prilosec OTC marketer Procter & Gamble

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A P&G petition revives the firm’s argument that future OTC proton pump inhibitors should be held to the same labeling language as Prilosec OTC. The firm also argues that the NDA process can allow labeling that unfairly gives some products marketplace advantages over category competitors.

P&G Targets Proposed Nexium Switch In Petition For PPI Labeling Limits

A P&G petition revives the firm’s argument that future OTC proton pump inhibitors should be held to the same labeling language as Prilosec OTC. The firm also argues that the NDA process can allow labeling that unfairly gives some products marketplace advantages over category competitors.

P&G Targets Proposed Nexium Switch In Petition For PPI Labeling Limits

A P&G petition revives the firm’s argument that future OTC proton pump inhibitors should be held to the same labeling language as Prilosec OTC. The firm also argues that the NDA process can allow labeling that unfairly gives some products marketplace advantages over category competitors.

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