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Letter

Document CHANTIX, 021928, Letter (Orange Book Sep. 19, 2014)
S-038 also includes additional proposed modifications to the approved risk evaluation and mitigation strategy (REMS), comprising further revisions to the Medication Guide as well as
To facilitate review of your submission, provide a highlighted or marked- up copy that shows all changes, as well as a clean Microsoft Word version.
In addition, the proposed modification includes revisions to the Chantix REMS goal to focus only on neuropsychiatric risks.
Alternatively, updates may be made by modifying the complete previous REMS supporting document, with all changes marked and highlighted.
should include prominent disclosure of the important new safety information that appears in the revised package labeling.
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Review

Document CHANTIX, 021928, Review (Orange Book Sep. 19, 2014)
The meta-analysis showed higher rates of CV endpoints in patients on CHANTIX relative to placebo across different time frames and pre-specified sensitivity analyses, including various study groupings and CV outcomes.
The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, Reference ID: 3630834 croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry® White (for 0.5 mg), Opadry® Blue (for 1 mg), and Opadry® Clear.
V arenicline blocks the ability of nicotine to activate 114(32 receptors and thus to stimulate the central nervous me.solimbic dopamine system, believed to be the neuronal mechanism underlying reinforcement and reward experienced upon smoking.
There was no evidence of a carcinogenic effect in mice administered varenicline by oral gavage for 2 years at doses up to 20 mg/kg/day (47 times the maximum recommended human daily exposure based on AUC).
Some people have had serious side effects while using CHANTIX to help them quit smoking, including: New or worse mental health problems, such as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions.
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Label

Document CHANTIX, 021928, Label (Orange Book Feb. 19, 2013)

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Label

Document CHANTIX, 021928, Label (Orange Book Jul. 22, 2011)

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Letter

Document CHANTIX, 021928, Letter (Orange Book Apr. 22, 2010)

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Review

Document CHANTIX, 021928, Review (Orange Book Apr. 22, 2010)

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Letter

Document CHANTIX, 021928, Letter (Orange Book Nov. 20, 2007)

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Letter

Document CHANTIX, 021928, Letter (Orange Book May. 10, 2006)

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