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FDA approves nicotine lozenge for smokers

Friday, November 1, 2002

WASHINGTON -- Smokers trying to quit will soon be able to try a nicotine-containing lozenge to help reduce their cigarette cravings.

The Food and Drug Administration approved GlaxoSmithKline's Commit lozenge for over-the-counter sales Thursday. It marks the first nicotine-containing lozenge to win the agency's approval.

The FDA last spring forced off the market nicotine lollipops that a number of pharmacists were manufacturing as an alternative to nicotine patches or gum for smoking cessation.

The FDA has maintained that smoking cessation products are drugs that require its approval to sell.

Another company, Star Scientific, sells a lozenge made of compressed tobacco that delivers a dose of nicotine equal to a cigarette. Because that product is sold not for smoking cessation but as an alternative to cigarettes when smokers can't puff -- such as during an airplane flight -- it argues the FDA can't regulate the product. At the request of attorneys general of 42 states, the FDA is reviewing that issue.

Glaxo's Commit lozenges come in varying amounts of nicotine. How long a smoker goes between cigarettes determines the recommended strength. Suck a lozenge when a craving quits, gradually lowering the number and strength ingested over a 12-week weaning period, the company says.

The lozenges, available without a prescription, will be available next month, in 72-lozenge packs for $39.95.


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