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LNK labeling deferral

This article was originally published in The Tan Sheet

Executive Summary

FDA grants LNK International deferral from "Drug Facts" labeling requirements for 19 OTCs until Dec. 31. In recent letter, agency says "we intend to exercise enforcement discretion" until year end based on LNK's May 31 application for exemption. Hauppauge, N.Y. firm noted additional time would enable it "to shift to a larger or alternative package style for these products to comply" with labeling final rule, FDA says. Per LNK's request, agency conducted "cursory review" of "Drug Facts" portion of 19 OTC draft labels and found "several content and format features in the 'Drug Facts' information that are not in compliance" with final rule. FDA notes its upcoming guidance on how reference listed drug, ANDA holders can update labeling consistent with "Drug Facts" format "may be particularly helpful to your company because several of the 19 products...are ANDA ibuprofen tablets, which this guidance will specifically address"...

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