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Generics proposal pulled

This article was originally published in The Tan Sheet

Executive Summary

FDA withdraws Aug. 6, 1999 proposed rule on 180-day generic exclusivity and ANDA approvals "in light of [court] decisions" invalidating agency's position on which rulings in patent infringement suits can trigger 180-day period. Proposal stated FDA would not start the clock until after a court decision from which no appeal could be taken, but a January 2000 D.C. federal court concluded 180 days was triggered by trial court decision on patent invalidity. Agency's most recent Hatch/Waxman proposed rule does not discuss the 180-day provision (1"The Tan Sheet" Oct. 28, 2002, p. 10). FDA will "carefully evaluate possible options for future rulemaking addressing 180-day exclusivity and the timing of ANDA approvals," agency says in 2Nov. 1 Federal Register notice...

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