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Pediatric exclusivity

This article was originally published in The Tan Sheet

Executive Summary

Generic associations file for injunction to stop further FDA implementation of the FDA Modernization Act's pediatric exclusivity provisions. The Generic Pharmaceutical Industry Association and the National Pharmaceutical Alliance argue in the suit, filed in D.C. federal court, that the agency's pediatric policy caters to interests of innovator companies rather than serving interests of children by extending exclusivity protections to products that, in some cases, are not even used in children. The associations cite the pediatric exclusivity award for Glaxo Wellcome's Zantac 75, marketed OTC by Warner-Lambert, as an example

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