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GATT "substantial investment" would require ANDA approval prior to June 1995.

This article was originally published in The Tan Sheet

Executive Summary

GATT "SUBSTANTIAL INVESTMENT" ELIGIBILITY WOULD REQUIRE ANDA ACCEPTANCE prior to June 8, 1995 under an amendment by Sens. Orrin Hatch (R-Utah) and Arlen Specter (R-Penn.). Offered as a substitute to legislation on marketing generic drugs during the extended patent period under the General Agreement on Tariffs and Trade, the amendment was adopted by the Judiciary Committee at a May 2 mark-up as a replacement for the bill (S 1277) sponsored by Sens. David Pryor (D-Ark.), Hank Brown (R-Colo.) and John Chafee (R-R.I.).
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