Watson Pharmaceuticals receives FDA approval for mint coated nicotine gum
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Watson Pharmaceuticals, Inc. has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavor, in the 2 mg and 4 mg strengths.
Nicotine Polacrilex Gum, coated mint flavor, is the generic equivalent of GlaxoSmithKline Consumer Healthcare’s Nicorette (R) fresh mint gum, which is used as an aid to smoking cessation. The market for over-the-counter nicotine gum had annual sales of over $300 million for the twelve months ending September 2008, according to IRI sales data. Watson will make the product available to customers in early January 2009.
“The approval of our mint flavored, coated nicotine gum is a significant addition to our line of generic smoking cessation products,” said Paul Bisaro, Watson’s President and Chief Executive Officer. “We also have applications pending at FDA for additional flavors and look forward further enhancing our line of smoking cessation products.”
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Nicotine gum has been in use for over 20 years to help smokers quit abruptly yet close to two-thirds of smokers report that they would prefer to quit gradually. Researchers from the University of Pittsburgh and GlaxoSmithKline Consumer Healthcare have now found that smokers who are trying to quit gradually can also be helped by
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