In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Nicotine patch labeling on preventing relapse suggested by McNeil.

This article was originally published in The Tan Sheet

Executive Summary

NICOTINE PATCH PREVENTING RELAPSE LABELING SUGGESTED BY McNEIL as a proposed revision of current labeling for OTC smoking cessation products. McNeil Consumer Products bases its comments on the clinical trial it submitted as part of its 1995 NDA for the Rx-to-OTC switch of the Nicotrol 15 mg nicotine patch. The comments are intended as a preview to FDA's June 9 Drug Abuse Advisory Committee meeting on revising nicotine patch labeling (mostly Rx products).





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts