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."