Skip to main content

FDA approves OTC nicotine gum


CORONA, Calif. Watson Pharmaceuticals on Wednesday announced that its subsidiary Watson Laboratories received approval from the 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 fresh mint gum. The market for over-the-counter nicotine gum had annual sales of more than $300 million for the 12 months ending September 2008, according to IRI sales data as provided by Watson. 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," stated Paul Bisaro, Watson president and chief executive officer. "We also have applications pending at FDA for additional flavors and look forward to further enhancing our line of smoking cessation products."

This ad will auto-close in 10 seconds