Perrigo ANDA approvals
This article was originally published in The Tan Sheet
Executive Summary
Private labeler is first to receive FDA approval for generic loperamide hydrochloride/simethicone chewable tablets (ANDA 76-029), equivalent to McNeil's Imodium Advanced, on Aug. 30. FDA nod comes about two months after Philadelphia federal judge deemed patent claims for Imodium Advanced invalid (1"The Tan Sheet" July 1, 2002, p. 3). Also on Aug. 30, Perrigo receives FDA approval of ANDA 76-195 for generic ranitidine tablets (Pfizer's Zantac 75)...
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