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Banner Pharmacaps petitions

This article was originally published in The Tan Sheet

Executive Summary

Softgel manufacturer requests FDA permit ANDA filing for loperamide hydrochloride 2 mg soft gelatin capsules, which have "the same active ingredient, [are] of the same strength and [are] expected to have the same therapeutic effect" as McNeil's Imodium A-D tablets but differ in dosage form. In an 1Aug. 5 citizen petition, Banner requests permission "to make an alternate dosage form available for those who have difficulty swallowing tablets or simply prefer the alternative." Generic softgel would be limited to consumers 12 and older, while Imodium tablets target children over six, but would otherwise carry identical labeling. In separate 2Aug. 8 petition, Banner requests FDA amend the OTC laxatives monograph "to state that docusate calcium...is an interchangeable ingredient with docusate sodium...in proposed monograph combinations," noting the different salts of docusate are considered identical...
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