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Exclusivity

This article was originally published in The Tan Sheet

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Executive Summary

Pediatric exclusivity for a brand name drug should not overlap with a generic firm's 180-day exclusivity, Sens. Orrin Hatch (R-Utah), Mike DeWine (R-Ohio) and Christopher Dodd (D-Conn.) say in a recent letter to FDA. Hatch/Waxman and FDAMA provisions "should be read in sequence so that any pediatric exclusivity that is granted does not run concurrently" with 180-day exclusivity, letter states. Senators urge FDA to "adopt a policy codifying this interpretation"

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