Nicotine Dependence
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FDA approval · 2012-11-29FDA Approved: GOOD NEIGHBOR PHARMACY NICOTINE — Supplemental Application (Amerisource Bergen)
FDA approved a supplemental application for Good Neighbor Pharmacy Nicotine (nicotine polacrilex) from AmerisourceBergen.
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FDA approval · 2012-11-29FDA Approved: BASIC CARE NICOTINE — Supplemental Application (Amazon.com Services LLC)
FDA approves a supplemental application for BASIC CARE NICOTINE (nicotine polacrilex) submitted by Amazon.com Services LLC.
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FDA approval · 2012-11-29FDA Approved: GOOD SENSE NICOTINE — Supplemental Application (L. Perrigo Company)
FDA approved a supplemental application for Good Sense Nicotine (nicotine polacrilex) by L. Perrigo Company. The product is a nicotine gum i…
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CLINICAL_TRIALS trial_result · 2012-11-27Clinical Trial Update: Efficacy of a Mobile Application in the Smoking Cessation Among Young People [NA]
This document reports on a clinical trial evaluating the efficacy of a mobile application to aid smoking cessation among young people. The s…
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CLINICAL_TRIALS trial_result · 2012-11-02Clinical Trial Update: A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent [Phase 2]
Phase 2 trial of Naltrexone SR/Bupropion SR for overweight and nicotine-dependent individuals has completed.
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CLINICAL_TRIALS trial_result · 2012-11-01Clinical Trial Update: Cue Induced Imaging in Nicotine Dependent Smokers
A clinical trial investigating cue-induced imaging in nicotine-dependent smokers has completed.
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FDA approval · 2012-10-09FDA Approved: NICOTINE MINI — Original Application (Walgreen Company)
FDA approves Walgreen Company's NICOTINE MINI (nicotine polacrilex) as an original ANDA, adding a generic nicotine replacement lozenge to th…
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FDA approval · 2012-09-28FDA Approved: QUITINE NICOTINE — Supplemental Application (QUITINE LLC)
FDA approved a supplemental application for QUITINE NICOTINE (nicotine polacrilex) from Quitine LLC.
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FDA approval · 2012-09-28FDA Approved: FOSTER AND THRIVE NICOTINE — Supplemental Application (Strategic Sourcing Services LLC)
FDA approved a supplemental application for Foster and Thrive Nicotine (nicotine polacrilex) from Strategic Sourcing Services LLC.
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FDA approval · 2012-09-20FDA Approved: NICOTINE TRANSDERMAL SYSTEM — Supplemental Application (Sam's West Inc)
The FDA approved a supplemental application for the Nicotine Transdermal System (nicotine patch) submitted by Sam's West Inc. The approval u…
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CLINICAL_TRIALS trial_result · 2012-09-19Clinical Trial Update: Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial. [Phase 4]
Phase 4 BEACON trial evaluating behaviorally enhanced counseling for nicotine dependence; results were posted in 2012 after study completion…
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FDA approval · 2012-09-18FDA Approved: NICORETTE — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for Nicorette (nicotine polacrilex) by Haleon US Holdings LLC. The approval updates the product's re…
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CLINICAL_TRIALS trial_result · 2012-09-11Clinical Trial Update: Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD) [NA]
Clinical trial update reporting results from a completed study evaluating an electronic nicotine delivery device (ENDD) for nicotine depende…
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CLINICAL_TRIALS trial_result · 2012-09-07Clinical Trial Update: Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study [NA]
A completed ADHD smoking cessation study with results posted in 2012; investigates nicotine dependence in individuals with ADHD.
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CLINICAL_TRIALS trial_result · 2012-09-05Clinical Trial Update: Gradual vs. Abrupt Cessation Treatment for Smoking [Phase 2]
Phase 2 clinical trial update comparing gradual versus abrupt cessation strategies for smoking cessation, with results posted in 2012.
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CLINICAL_TRIALS trial_result · 2012-09-05Clinical Trial Update: An Internet-Based Smokeless Tobacco Cessation Program for Teens [Phase 2]
Phase 2 clinical trial update for an internet-based smokeless tobacco cessation program targeting teens; the study has completed.
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FDA approval · 2012-08-01FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
FDA approved a supplemental application for Nicorette 4 mg Fruit Chill Gum marketed by Lil' Drug Store Products, confirming authorization fo…
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FDA approval · 2012-08-01FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for NICORETTE ORIGINAL (nicotine polacrilex) from Haleon US Holdings LLC.
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CLINICAL_TRIALS trial_result · 2012-07-27Clinical Trial Update: Investigation of Cycloserine as a Smoking Cessation Treatment [Phase 1]
This clinical trial update reports the completion of a Phase 1 study evaluating cycloserine as a treatment to help people quit smoking (nico…
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CLINICAL_TRIALS trial_result · 2012-07-18Clinical Trial Update: Long-term Varenicline Treatment for Smoking Cessation [Phase 4]
A Phase 4 study evaluating long-term varenicline use for smoking cessation has completed, with results posted in 2012.
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CLINICAL_TRIALS trial_result · 2012-07-18Clinical Trial Update: Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3 [NA]
A completed clinical trial evaluating the effects of nicotine patch use in male and female smokers. The study examined outcomes related to n…
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FDA approval · 2012-07-16FDA Approved: NICORETTE 4MG FRUIT CHILL GUM, LIL DRUG STORE — Supplemental Application (Lil' Drug Store Products, Inc.)
The FDA approved a supplemental application for Nicorette 4 mg Fruit Chill Gum from Lil’ Drug Store Products, Inc., allowing continued marke…
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FDA approval · 2012-07-16FDA Approved: NICORETTE ORIGINAL — Supplemental Application (Haleon US Holdings LLC)
FDA approved a supplemental application for Nicorette Original (nicotine polacrilex) from Haleon US Holdings LLC. The approval indicates reg…
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CLINICAL_TRIALS trial_result · 2012-07-10Clinical Trial Update: Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge [Phase 2]
Phase 2 trial update reports on early effects of a new oral nicotine replacement product used in combination with NiQuitin Lozenge for smoki…
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CLINICAL_TRIALS trial_result · 2012-07-10Clinical Trial Update: Photoirritation and Photoallergic Potential of a New Nicotine Patch [Phase 1]
Phase 1 study assessing whether a new nicotine patch causes photoirritation or photoallergic reactions when exposed to light. The trial focu…