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PPA

This article was originally published in The Tan Sheet

Executive Summary

Statement disclaiming product liability relevance of FDA's decision to remove PPA from OTC cough/cold products should be included in final withdrawal determination, Novartis, Schering-Plough assert in separate comments to agency. Both firms request FDA issue a disclaimer resembling one used in a March 1999 final action, which states: "The agency wishes to emphasize that the inclusion of a drug product on the list does not mean that the drug product was marketed negligently, was defective or was marketed in breach of any warranty." FDA hearing on proposed PPA withdrawal is unnecessary as all products containing ingredient were pulled from shelves after de facto recall last November, firms say
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