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About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Nicorette (nicotine polacrilex)

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: SmithKline Beecham
Approval Status: Approved February 1996
Treatment for: smoking cessation

General Information

Nicorette has been approved as an over-the-counter (OTC) aid in smoking cessation. The OTC nicotine gum product will be available in the same dosage strengths as the prescription product.

Nicorette relieves withdrawal symptoms by providing a temporary alternative source of nicotine, thereby easing the transition for an individual committed to smoking cessation. The nicotine in Nicorette reaches the bloodstream more gradually and at lower doses than delivered by cigarettes. While Nicorette controls withdrawal symptoms, thus addressing the physical addiction of smoking, the individual works to control the social and psychological aspects of the smoking habit.

The OTC version of Nicorette will be available in prescription strengths of 2 mg and 4 mg.


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Drug listing last updated on June 20, 2008

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