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180-Day Exclusivity Must Begin Within 180-Day "Triggering Period" - FDA

This article was originally published in The Tan Sheet

Executive Summary

Generic drug firms eligible for 180 days of marketing exclusivity would lose their eligibility if the exclusivity period were not triggered within 180 days of tentative approval of another ANDA referencing the same listed drug. FDA spells out this condition in an Aug. 6 proposed rule.
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