Smoking Cessation Labels Cleared Without Duration-Of-Use Limit
This article was originally published in The Tan Sheet
FDA approved labeling for Nicorette and NicoDerm CQ nicotine replacement therapies, removing some risk information that industry and the agency agree is outdated and unnecessarily restrictive.
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GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.
FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.
FDA drops its requirement for labeling provisions for NRTs on duration of use and concomitant use of tobacco or other NRTs. Meanwhile, the agency rejects citizen petition requests for additional NRT indications, but says it is open to working with sponsors on developing those indications.