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Perrigo labeling deferrals

This article was originally published in The Tan Sheet

Executive Summary

FDA grants private labeler's request for varying deferral dates from OTC labeling final rule, depending on when agency labeling templates become available (1"The Tan Sheet" Oct. 1, p. 3). In Dec. 11 letter, FDA concludes that based on amount of time it has taken to finalize labeling templates for several ANDA drug products, "we consider your timetable for concurrent implementation of labeling revisions for [these] products to be appropriate." Implementation deferrals apply to clemastine fumarate tablets, doxylamine succinate tablets, pseudoephedrine HCl extended release and minoxidil topical solution, all of which did not have finalized FDA labeling templates as of Oct. 1...

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