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Habitrol labeling changes

This article was originally published in The Tan Sheet

Executive Summary

FDA approves supplemental NDA 20-076/S-021 for labeling changes to Novartis' Habitrol smoking cessation patch on July 15. New packaging will incorporate current pregnancy/breastfeeding warning, as requested by FDA in 2001 (1"The Tan Sheet" August 27, 2001, p. 3). Changes will appear on "Drug Facts" box of 7 mg, 14 mg and 21 mg Habitrol cartons. Revised labeling also will be reflected on multi-dose Habitrol kit, which was approved as the first 3-in-1 smoking cessation offering in July (2"The Tan Sheet" July 22, 2002, p. 4)...

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